Novel Drugs 2022 CE Update

Samuel Hwang, Pharm.D.

Clinical Pharmacist Fellow in Drug Information
Belmont University/Aegis Sciences Corporation
&
Samantha Triplett, Pharm.D.
Clinical Management Fellow in Drug Information
Belmont University/HealthTrust

Preceptor: Genevieve Lynn (Ness) Engle, Pharm.D. BCMAS

Director, Christy Houston Foundation Drug Information Center/Associate
Professor of Pharmaceutical, Social and Administrative Sciences
Belmont University College of Pharmacy

FROM HERE TO ANYWHERE

 Samuel Hwang, Pharm.D. Samantha Triplett, Pharm.D.
Clinical Pharmacist Fellow in Drug Information Clinical Management Fellow in Drug
Belmont University/Aegis Sciences Corporation Information
Belmont University/HealthTrust

FROM HERE TO ANYWHERE

 Financial Disclosures
• Samuel Hwang, Samantha Triplett, and Genevieve Lynn (Ness)
Engle, authors of this educational activity, have no relevant financial
relationships with ineligible companies to disclose.

• None of the planners for this educational activity have relevant

financial relationships to disclose with ineligible companies whose
primary business is producing, marketing, selling, re-selling, or
distributing healthcare products used by or on patients.

FROM HERE TO ANYWHERE

 Objectives
1. Recognize the new molecular entities approved by the Food and Drug
Administration (FDA) in 2022

2. Describe the indications & drug class of the new drugs

3. Explain common adverse events, available dosage forms, and clinical

pearls of the new drugs

4. Discuss the potential role of these newly approved drugs in current

pharmacy practice
FROM HERE TO ANYWHERE
 FDA Novel Drug Approvals by Year

59
53
41 46 48 50
39 45
30 27 37
22

Novel Drug Approvals for 2022. U.S. Food and Drug Administration. Updated December 29, 2022. Accessed January 9, 2023.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 FROM HERE TO ANYWHERE
 2022 Statistics

• Priority: 21/37
• Type 1-New Molecular Entity: 21/37
• Type 4-New Combination: 2/37 21 21 20
• Orphan: 20/37
2

Novel Drug Approvals for 2021. U.S. Food and Drug Administration. Updated January 6, 2022. Accessed January 7, 2022.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021 FROM HERE TO ANYWHERE
2022 Approvals

FROM HERE TO ANYWHERE

Psoriasis

FROM HERE TO ANYWHERE

 Vtama®
tapinarof (ta-PIN-ar-of)
Approval Date​ 5/23/2022 Type 1-New Molecular Entity, STANDARD
Indication​ Treat plaque psoriasis

Class​ Aryl hydrocarbon receptor (AhR) agonist

Mechanism of Action Binds to and actives the aryl hydrocarbon receptor (AhR) which regulates cytokine
and skin-barrier-protein expression (e.g., filaggrin, hornerin, and involucrin) to
restore the skin barrier and epidermal function and decrease oxidative stress

Common Adverse Events (1-10%) Folliculitis (20%), nasopharyngitis (11%), contact dermatitis (7%), pruritus (3%),
influenza (2%), headache (4%)

Dosage Forms​ External topical cream

Novel Attributes First-in-Class

Cost (WAC) 60 gm 1% topical cream: $1325.00 per tube

Tapinarof. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 4, 2022. Accessed January 10, 2023. https://online.lexi.com
Tapinarof. DrugBank. November 18, 2007. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB06083
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
 Sotyktu®
deucravacitinib (deu-krav-a-sye-ti-nib)

Approval Date​ 9/9/2022 Type 1-New Molecular Entity, STANDARD

Indication​ Treatment of moderate-to-severe plaque psoriasis

Class​ Janus Kinase Inhibitor/Tyrosine Kinase 2 Inhibitor/Tyrosine Kinase Inhibitor

Mechanism of Action Inhibits tyrosine kinase 2 (TYK2) by binding to the regulatory domain of TYK2,
leading to the inhibition of downstream activation of Signal Transducers and
Activators of Transcription (STATs)
Common Adverse Events Infection (29%), upper respiratory tract infection (19%), acne vulgaris (1%), oral
mucosa ulcer (2%)
Dosage Forms​ Tablet
Novel Attributes First-in-Class

Cost (WAC) 6 mg: $6164.38 per 30 tablets ($205.48 per tablet)

Deucravacitinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
Deucravacitinib. DrugBank. March 24, 2021. Updated December 6, 2022. Accessed January 10, 2023.
https://go.drugbank.com/drugs/DB16650
Sotyktu. Package insert. Bristol-Myers Squibb Company; 2022 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Spevigo®
spesolimab-sbzo

Approval Date​ 9/1/2022 PRIORITY; Orphan

Indication​ Generalized pustular psoriasis flares

Class​ Interleukin-36 receptor antagonist, monoclonal antibody

Mechanism of Action Inhibits interleukin-36 (IL-36) by binding to the IL-36 receptor, preventing activation of
IL36R and downstream pro-inflammatory and pro-fibrotic pathways

Common Adverse Events Infection (14%), cellulitis (3%), nausea and vomiting (<3%)
Dosage Forms​ Intravenous solution
Novel Attributes First-in-Class
First approved for disease
Breakthrough Therapy

Cost (WAC) 60 mg/1 mL solution: $51133.00 for two 7.5 mL vials ($25,566.50 per vial)

Spesolimab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
Spevigo. Package insert. Boehringer Ingelheim Pharmaceuticals; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Dermatitis

FROM HERE TO ANYWHERE

 Cibinqo®
abrocitinib (A-broe-SYE-ti-nib)
Approval Date​ 1/14/2022 PRIORITY; Type 1-New Molecular Entity

Indication​ To treat refractory, moderate-to-severe atopic dermatitis

Class​ Janus Kinase Inhibitor
Mechanism of Action Prevents signaling of interleukin-4, interleukin-13, and other cytokines by reversibly
blocking the adenosine triphosphate binding site of the JAK1 enzyme

Common Adverse Events (>10%) Nausea, infection, nasopharyngitis

Dosage Forms​ Oral tablets

Novel Attributes Breakthrough Therapy

Cost (WAC) 50 mg; 100 mg; 200 mg: $5302.21 per 30 tablets ($176.74 per tablet)

Abrocitinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Eschar Removal

FROM HERE TO ANYWHERE

 NexoBrid®
anacaulase-bcdb
Approval Date​ 12/28/2022 Orphan

Indication​ Eschar removal for adults with deep partial/full thickness

thermal burns
Class​ Debridement, Enzyme

Mechanism of Dissolves burn wound eschar

Action

Common Adverse Pruritus (15%), pyrexia (2%), vomiting (5%), urinary tract
Events infection (4%), anemia (6%)

Dosage Forms​ Topical gel

Cost (WAC) 8.8% strength 55 g gel: $3150.00 per tube

Anacaulase. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 13, 2023. https://online.lexi.com
NexoBrid. Package insert. MediWound; 2022 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 13, 2023. https://www.micromedexsolutions.com/
Moderate-to-Severe
Glabellar Lines
FROM HERE TO ANYWHERE
 Daxxify®
daxibotulinumtoixnA-lanm (dax-i-bot-ue-lye-num-tox-in-ay)

Approval Date​ 9/27/2022

Indication​ Glabellar lines

Class​ Neuromuscular blocker agent

Mechanism of Action Reversible inhibition of acetylcholine release, resulting in decreased muscle function

Common Adverse Events Edema (2%), Injection site reaction (9%), headache (5 - 6%)

Dosage Forms​ Intramuscular solution

Cost (WAC) Not available

DaxibotulinumtoixnA. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 5, 2022. Accessed January 17, 2023.
https://online.lexi.com FROM HERE TO ANYWHERE
Daxxify. Package insert. Revance Therapeutics Inc; 2022
Insomnia

FROM HERE TO ANYWHERE

 Quviviq®
daridorexant (DAR-i-doe-REX-ant)

Approval Date​ 1/7/2022 Type 1-New Molecular Entity

Indication​ Insomnia, sleep onset or maintenance

Class​ Orexin receptor antagonists

Schedule IV

Mechanism of Action Antagonism of neuropeptides orexin A and B to receptors OX1R and OX2R

Common Adverse Events (1 - 10%) Drowsiness, fatigue, headache, dizziness

Dosage Forms​ Oral tablet

Cost (WAC) 25 mg and 50 mg: $479.85 per 30 count, $16.00/tablet

Daridorexant. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 11, 2022. Accessed January 9, 2023. https://online.lexi.com
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 9, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
Quviviq. Package insert. Idorsia Pharmaceuticals; 2022.
Seizures

FROM HERE TO ANYWHERE

 Ztalmy®
ganaxolone (gan-AX-oh-lone)
Approval Date​ 3/18/2022 PRIORITY; Orphan; Type 1-New Molecular Entity

Indication​ To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder in patients ≥2

years and older

Class​ Anti-seizure medication

Mechanism of Action Positive allosteric GABAA modulation result in anxiolytic, sedative, and anticonvulsant
effects. GABAA sites are distinct from the benzodiazepine binding site

Common Adverse Events Drowsiness (including lethargy and hypersomnia), fever

(≥10%)

Dosage Forms​ Oral suspension

Novel Attributes First-in-Class

Cost (WAC) 50 mg/1 mL suspension: $2425.00 per 110 mL vial

Ganaxolone. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 28, 2022. Accessed January 10, 2023. https://online.lexi.com
Ganaxolone. DrugBank. October 21, 2007. Updated April 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB05087 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Multiple Sclerosis

FROM HERE TO ANYWHERE

 Briumvi®
ublituximab-xiiy (UE-bli-TUX-i-mab)
Approval Date​ 12/28/2022

Indication​ To treat relapsing multiple sclerosis

Class​ Anti-CD20 monoclonal antibody

Mechanism of Action Binds to CD20 which causes cell lysis through cellular cytolysis

Common Adverse Events (>10%) Decreased neutrophils, infection, upper respiratory tract infection, infusion-related
reactions, decreased serum immunoglobulins

Dosage Forms​ Intravenous solution

Cost (WAC) 150 mg/6 mL solution: $9833.33 per 6 mL vial

Ublituximab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
Briumvi. Package insert. TG Therapeutics; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Polyneuropathy

FROM HERE TO ANYWHERE

 Amvuttra®
vutrisiran (VUE-tri-SIR-an)

Approval Date​ 6/13/2022 Orphan; Type 1-New Molecular Entity

Indication​ Polyneuropathy associated with hereditary transthyretin-mediated amyloidosis

Class​ Anti-transthyretin small interfering ribonucleic acid (siRNA) agent

Mechanism of Action Double stranded small interfering ribonucleic acid (siRNA) that is conjugated to a ligand
containing three N-acetylgalactosamine (GaINAc) that causes degradation of mutant
and wild-type transthyretin (TTR) mRNA through RNA interference

Common Adverse Events Arthralgia (11%), vitamin A deficiency (7%), antibody development (3%), dyspnea (7%)

Dosage Forms​ Prefilled syringe solution

Cost (WAC) 25 mg/0.5 mL syringe: $119351.00

Vutrisiran. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 3, 2022. Accessed January 19, 2023. https://online.lexi.com
Amvuttra. Package insert. Alnylam Pharmaceuticals, Inc.; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 19, 2023. https://www.micromedexsolutions.com/
Amyotrophic Lateral
Sclerosis
FROM HERE TO ANYWHERE
 Relyvrio®
sodium phenylbutyrate/taurursodiol
(SOW-dee-um-fen-il-BYOO-ti-rate and UR-so-DYE-ol)
Approval Date​ 9/29/2022 Orphan

Indication​ Amyotrophic lateral sclerosis

Class​ Histone deacetylase inhibitor, hydrophilic bile acid

Mechanism of Action Unknown, reduces neuronal cell death through reduction of endoplasmic reticulum
stress and mitochondrial dysfunction in vitro

Common Adverse Events (>10%) Abdominal pain (21%), diarrhea (25%), nausea (18%), sialorrhea (11%), fatigue
(12%), upper respiratory tract infection (18%), dizziness (10%)

Dosage Forms​ Oral packet

Cost (WAC) 3g/1g packet: $1563.03 per 7 packets ($223.29 per 1 packet)

Sodium phenylbutyrate/taurursodiol. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 14, 2023. Accessed January 19,2023.
https://online.lexi.com
Relyviro. Package insert. Amylyx Pharmaceuticals Inc.; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 19, 2023. https://www.micromedexsolutions.com/
 Question 1

Which of the following medications are used for seizures?

a. ganaxolone
b. gadopiclenol
c. oteseconazole
d. vonoprazan + amoxicillin + clarithromycin

Objective 1: Recognize the new molecular entities approved by the Food and Drug Administration (FDA) in 2022

FROM HERE TO ANYWHERE

Intraocular
Pressure
FROM HERE TO ANYWHERE
 Omlonti®
omidenepag isopropyl ophthalmic solution
Approval Date​ 9/22/2022 Type 1-New Molecular Entity

Indication​ Reduce intraocular pressure in patients with ocular

hypertension or open-angle glaucoma

Class​ Prostaglandin E2 (EP2) agonist

Mechanism of Selectively binds to EP2 receptors and decreases

Action intraocular pressure
Common Adverse Headache (2%), blurred vision (4%), conjunctival hyperemia
Events (9%), photophobia (5%)

Dosage Forms​ Ophthalmic solution

Cost (WAC) Not available

Oomidenepag isopropyl. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 11, 2022. Accessed January 13, 2023.
https://online.lexi.com
Omlonti. Package insert. Santen Incorporated; 2022.
Oomidenepag isopropyl. DrugBank. May 20, 2019. Updated December 1, 2022. Accessed January 13, 2023. FROM HERE TO ANYWHERE
https://go.drugbank.com/drugs/DB15071
 Macular
Degeneration and
Diabetic Macular
Edema FROM HERE TO ANYWHERE
 Vabysmo®
faricimab-svoa (far-IK-i-mab)
Approval Date​ 1/28/2022

Indication​ To treat neovascular (wet) age-related macular degeneration and diabetic macular
edema

Class​ Vascular Endothelial Growth Factor (VEGF) Inhibitor

Mechanism of Action Causes suppression of endothelial cell proliferation, neovascularization, and

vascular permeability by inhibiting vascular endothelial growth factor A (VEGF-A).
Faricimab also promotes vascular stability and desensitizes blood vessels to the
effects of VEGF-A by inhibiting angiopoietin-2 (Ang-2).

Common Adverse Events (>1%) Arterial thromboembolism, antibody development, conjunctival hemorrhage, eye
pain, increased intraocular pressure, intraocular inflammation, retinal pigment
epithelium tear, vitreous opacity

Dosage Forms​ Intravitreal injection

Cost (WAC) 6 mg/0.05 mL solution: $2190.00 per 0.05 mL vial

Faricimab-svoa. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 2, 2022. Accessed January 10, 2023.
https://online.lexi.com FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Diabetes

FROM HERE TO ANYWHERE

 Mounjaro®
tirzepatide (tir-ZEP-a-tide)

Approval 5/13/2022 PRIORITY; Type 1-New Molecular Entity

Date​
Indication​ Improve blood sugar control in type 2 diabetes, in
addition to diet and exercise

Dosage Subcutaneous pen-injector

Class Glucose-Dependent Insulinotropic Polypeptide Forms​
(GIP)/Glucagon-Like Peptide (GLP-1) receptor
agonist
Novel First-in-Class
Mechanism Increases glucose-dependent insulin secretion, Attributes
of Action decreases inappropriate glucagon secretion, and
slows gastric emptying
Cost 2.5 mg/0.5 mL; 5 mg/0.5 mL; 7.5
Common Decreased appetite (5% to 11%), diarrhea (12% to (WAC) mg/0.5 mL; 10 mg/0.5 mL; 12.5
Adverse 17%), increased serum amylase (33% to 38%), mg/0.5 mL; 15 mg/0.5 mL solution:
Events increase serum lipase (31% to 42%), nausea (12% $1023.04 per 4 pens ($255.76 per
(≥10%) to 18%) pen)

Tirzepatide. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 30, 2022. Accessed January 10, 2023. https://online.lexi.com
Tirzepatide. DrugBank. May 20, 2019. Updated December 23, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB15171 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Tzield®
teplizumab-mazw (tep-LIZ-ue-mab)

Approval Date​ 11/18/2022 PRIORITY

Indication​ Type 1 diabetes mellitus, delay onset of symptomatic disease (stage 3) in adults
and children ≥8 years of age
Class​ Anti-CD3 antibody
Mechanism of Action Binds to CD3 (cell surface antigen on T lymphocytes) on CD4+ and CD8+ T cells,
increases regulatory T cells and exhausted CD8+ T cells in blood, involves partial
agonistic signaling and deactivation of pancreatic beta cell autoreactive T
lymphocytes
Common Adverse Events (>10%) Skin rash, leukopenia, lymphocytopenia, headache
Dosage Forms​ Intravenous solution
Novel Attributes First-in-Class
First drug approved for indication
Breakthrough Therapy
Cost (WAC) 2 mL vial: $13850.00

Teplizumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 19, 2023. Accessed January 19, 2023. https://online.lexi.com
Tzield. Package insert. Provention Bio, Inc.; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 19, 2023. https://www.micromedexsolutions.com/
Cardiovascular

FROM HERE TO ANYWHERE

 Camzyos®
mavacamten (ma-VA-cam-ten)
Approval Date​ 4/28/2022 Orphan; Type 1-New Molecular Entity
Indication​ Treatment of NYHA Class II to III obstructive hypertrophic cardiomyopathy

Class​ Cardiac myosin inhibitor

Mechanism of Action An allosteric and reversible inhibitor selective for cardiac myosin, that modulates the
number of myosin heads that cross-bridge to actin during systole or diastole, promoting
an energy-sparing, recruitable, super-relaxed state, reducing dynamic left ventricular
outflow tract obstruction, improving cardiac filling pressures
Common Adverse Events Dizziness (27%), decreased left ventricular ejection fraction (6%), syncope (6%)
Dosage Forms​ Oral capsule
Novel Attributes First-in-Class
Breakthrough Therapy
Cost (WAC) 2.5 mg; 5 mg; 10 mg; 15 mg: $7797.53 for 30 capsules ($259.92 per capsule)

Mavacamten. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022. Accessed January 10, 2023. https://online.lexi.com
Mavacamten. DrugBank. May 20, 2019. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB14921
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
 Question 2

What is the indication of mavacamten?

a. Treat NYHA Class II to III obstructive hypertrophic
cardiomyopathy
b. Treat NYHA Class II to IV obstructive hypertrophic
cardiomyopathy
c. Treat patients with COPD to reduce mortality associated
with heart failure
d. Treat NYHA Class I to III obstructive hypertrophic
cardiomyopathy
Objective 2: Describe the indications & drug class of the new drugs

FROM HERE TO ANYWHERE

Anemia

FROM HERE TO ANYWHERE

 Pyrukynd®
mitapivat (MYE-ta-PIV-at)
Approval Date​ 2/17/2022 PRIORITY; Orphan, Type 1-New Molecular Entity

Indication​ To treat hemolytic anemia in pyruvate kinase deficiency

Class​ Pyruvate kinase activator

Mechanism of Action Allosteric red-cell pyruvate kinase (PK) activator that binds to the PK tetramer, leading
to increased PK activity

Common Adverse Decreased plasma estradiol concentration (including estrone; males: ≤56%),
Events (≥10%) increased uric acid, back pain

Dosage Forms​ Oral tablet

Novel Attributes First-in-Class

Cost (WAC) ● 5 mg: $3,220.00 for 7 tablets ($460.00 per tablet)

● 5 mg; 20 mg; 50 mg: $25,760.00 for 56 tablets ($460.00)
● 5 mg, 20 mg taper pack; 20 mg; 50 mg taper pack: $6440.00 per 14 tablets
($460.00)
Mitapivat. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2021. Updated May 18, 2022. Accessed June 6, 2022. https://online.lexi.com
Mitapivat. DrugBank. December 15, 2022. Updated March 8, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB16236 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
Hemolysis in Cold
Agglutinin Disease
FROM HERE TO ANYWHERE
 Enjaymo®
sutimlimab-jome (soo-TIM-li-mab)
Approval Date​ 2/4/2022 PRIORITY; Orphan

Indication​ To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin
disease

Class​ Complement inhibitor, monoclonal antibody

Mechanism of Action Inhibits the complement cascade at the level of C1s, preventing deposite of complement
opsonins on RBC surfaces, resulting in inhibition of hemolysis in cold agglutinin disease

Common Adverse Events (>10%) Peripheral edema, skin infection, diarrhea, dyspepsia, serious infection (including
sepsis), viral infection, arthralgia, arthritis, cough, respiratory tract infection

Dosage Forms​ Intravenous solution

Novel Attributes First-in-Class

Breakthrough Therapy

Cost (WAC) 50 mg/1 mL solution: $1880.00 per 22 mL vial

Sutimlimab-jome. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
 Acid
Sphingomyelinase
Deficiency
FROM HERE TO ANYWHERE
 Xenpozyme®
olipudase alfa
Approval Date​ 8/31/2022 PRIORITY; Orphan
Indication​ Acid Sphingomyelinase (ASM) deficiency
Class​ Recombinant human acid sphingomyelinase, enzyme
Mechanism of Action Exogenous source of the ASM enzyme, deficiency of the ASM enzyme leads to intra-
lysosomal accumulation of spingomyelin along with cholesterol and other lipids in the
tissues

Common Adverse Events Hypotension, tachycardia, pruritus, skin rash, abdominal pain, nausea, vomiting
(>10%)

Dosage Forms​ Intravenous powder, vial

Novel Attributes First-in-Class
Breakthrough Therapy

Cost (WAC) 20 mg powder: $7142.00 per vial

Olipudase alfa. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022. Accessed January 17, 2023. https://online.lexi.com
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 17, 2023. https://www.micromedexsolutions.com/
Xenpozyme. Package insert. Genzyme Corporation; 2022. FROM HERE TO ANYWHERE
Kidney Function

FROM HERE TO ANYWHERE

 Terlivaz®
terlipressin (ter-li-PRES-sin)

Approval Date​ 9/14/2022 PRIORITY; Orphan; Type 1-New Molecular Entity

Indication​ Hepatorenal syndrome with rapid reduction in kidney function
• Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit
Class​ H01BA04 vasopressin receptor agonist
Mechanism of Action A synthetic vasopressin analogue that produces an extended duration of systemic
vasoconstriction through the conversion of lysine-vasopressin by means of a slow
enzymatic cleavage
Common Adverse Events (>10%) Respiratory failure (16%; severe: 14%), dyspnea (13%), nausea (16%), abdominal
pain (20%), diarrhea (13%)
Dosage Forms​ 0.85 mg vial: a white to off-white lyophilized powder in a single dose vial for
reconstitution
Novel Attributes First-in-Class
First drug approved for indication
Cost (WAC) 0.85 mg vial: $950.00

Terlipressin. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022 . Accessed January 17, 2023. https://online.lexi.com
Terlivaz. Package insert. Mallinckrodt; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 17, 2023. https://www.micromedexsolutions.com/
Antibiotics

FROM HERE TO ANYWHERE

 Voquezna® Vonoprazan

vonoprazan (von-OH-pra-zan) amoxicillin, and clarithromycin

Approval Date​ 5/3/202 PRIORITY; Type 1-New Molecular Entity and Type 4-New Combination;
Type 5-New Formulation or New Manufacturer
Indication​ Treatment of Helicobacter pylori infection
Class​ Penicillin/Potassium-competitive acid blocker
Mechanism of Action Competitively inhibits the binding of potassium ions to the enzyme system of
hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase)
Common Adverse Events (≥2%) ● Dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain,
hypertension
● Monitor for drug interactions with clarithromycin
Dosage Forms​ Oral
Novel Attributes First-in-Class
Cost (WAC) 500 mg, 20 mg kit (Dual Pak) and 500 mg, 500 mg, 20 mg kit (Triple Pak): $812.00
per 112 tablet ($7.25 per tablet)

Vonoprazan. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 17, 2022. Accessed January 10, 2023. https://online.lexi.com
Voquezna. Package insert. Phathom Pharmaceuticals, Inc.; 2022.
Vonoprazan. DrugBank. October 20, 2016. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB11739
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
FROM HERE TO ANYWHERE
Vulvovaginal
Candidiasis
FROM HERE TO ANYWHERE
 Vivjoa®
oteseconazole (oh-TES-e-KON-a-zole)
Approval Date​ 4/26/2022 PRIORITY; Type 1-New Molecular Entity

Indication​ Reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females

with a history of RVVC who are not of reproductive potential

Class​ Azole derivative/antifungal agent

Mechanism of Action Azole metalloenzyme inhibitor of the fungal sterol, 14 alpha demethylase
(CYP51), which results in accumulation of membrane disrupting 14-
methylated sterols
Common Adverse Hot flash, dyspepsia, nausea, dysuria, heavy menstrual bleeding (including
Events (1-10%) uterine hemorrhage and vaginal hemorrhage), vulvovaginal irritation
(including vulvovaginal burning and vaginal pain), headache (including
migraine and sinus headache), increased creatine phosphokinase in blood
specimen
Dosage Forms​ Oral capsules

Cost (WAC) 150 mg: $2808.00 for 18 capsules ($156.00 per capsule)

Oteseconazole. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 5, 2022. Accessed January 10, 2023. https://online.lexi.com
Oteseconazole. DrugBank. October 21, 2016. Updated May 3, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB13055
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
FROM HERE TO ANYWHERE
HIV

FROM HERE TO ANYWHERE

 Sunlenca®
lenacapavir
Approval Date​ 12/22/2022 PRIORITY; Type 1-New Molecular Entity
Indication​ Used to treat patients with HIV who have failed many other treatments, and cannot be treated
with other drugs available due to resistance, intolerance, or safety concerns

Class​ Antiretroviral, capsid inhibitor

Mechanism of Action Capsid inhibitor which interferes with the virus’s ability to assemble capsid protein subunits
which leads to malformation of capsids

Common Adverse Events (≥10%) Local injection site reaction (65%); including: injection site swelling (36%), induration at injection
site (15%), injection site erythema (31%), pain at injection site (31%), and injection site nodule
(25%)

Dosage Forms​ Tablet, subcutaneous solution

Novel Attributes First-in-Class
Breakthrough Therapy

Cost (WAC) 300 mg: $3250.00 per 4 tablets or $4062.50 per 5 tablets ($812.50 per tablet)
309 mg/1 mL solution: $19500 per 1.5 mL vial ($39000 per dose)

Lenacapavir. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
Capsid Inhibitor(s). Clinical Info HIV. Accessed January 13, 2023. https://clinicalinfo.hiv.gov/en/glossary/capsid-inhibitors
Lenacapavir. DrugBank. April 20, 2020. Updated December 31, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15673
Sunlenca. Package insert. Gilead Sciences; 2022
FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 13, 2023. https://www.micromedexsolutions.com/
 Sunlenca®
lenacapavir

Initiation and Maintenance

Initiation Option 1 Day 1: 927 mg subcutaneous injection once (2 x 1.5 mL injections) OR 600 mg by
mouth once (2 x 300 mg tablets)
Day 2: 600 mg by mouth once (2 x 300 mg tablets)

Initiation Option 2 Day 1: 600 mg by mouth once (2 x 300 mg tablets)

Day 2: 600 mg by mouth once (2 x 300 mg tablets)
Day 8: 300 mg by mouth once (1 x 300 mg tablets)
Day 15: 927 mg subcutaneous injection once (2 x 1.5 mL injections)

Maintenance 927 mg subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks)
from the date of last injection, ±2 weeks

Lenacapavir. DrugBank. April 20, 2020. Updated December 31, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15673 FROM HERE TO ANYWHERE
Sunlenca. Package insert. Gilead Sciences; 2022
 Question 3

For lenacapavir, how many weeks can a dose be missed

before having to restart initiation from day 1?
a. 32 weeks
b. 20 weeks
c. 38 weeks
d. 28 weeks

Objective 3: Explain common adverse events, available dosage forms, and clinical pearls of the new drugs

FROM HERE TO ANYWHERE

Oncology

FROM HERE TO ANYWHERE

 Opdualag®
nivolumab and relatlimab-rmbw (nye-VOL-ue-mab & rel-AT-li-mab)
Approval Date​ 3/18/2022 PRIORITY; Orphan
Indication​ To treat unresectable or metastatic melanoma
Class​ Antineoplastic, monoclonal antibody
Mechanism of Action Promotes T cell proliferation and cytokine secretion by blocking interaction
between LAG-3 and its ligands (including MHC II) to reduce LAG-3 pathway-
mediated immune response inhibition

Common Adverse Events Pruritus, skin rash, vitiligo, decreased serum sodium, hypothyroidism, decreased
(≥10%) appetite, diarrhea, nausea, lymphocytopenia, increased serum alanine
aminotransferase, increased serum alkaline phosphatase, increased serum
aspartate aminotransferase, fatigue, headache, musculoskeletal pain, increased
serum creatine, cough

Dosage Forms​ Intravenous solution

Novel Attributes First-in-Class
Cost (WAC) 12 mg/1 ml-4 mg/1 mL: $13968.16 per 20 mL vial

Nivolumab and Relatlimab-rmbw. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 19, 2022. Accessed January 10, 2023.
https://online.lexi.com
Melanoma: cutaneous. National Comprehensive Cancer Network. Updated December 22, 2022. Accessed January 10, 2023.
FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Kimmtrak®
tebentafusp-tebn
Approval Date​
1/25/2022 PRIORITY; Orphan
Indication​
To treat unresectable or metastatic uveal melanoma
Class​ Anti-CD3, bispecific T-cell engager
Mechanism of Action The T-cell receptor binds to a glycoprotein 100 peptide presented by HLA-A*02:01 on the surface
of uveal melanoma tumor cells, recruiting and activating polyclonal T-cells to release
inflammatory cytokines and cytolytic proteins, resulting in direct lysis of uveal melanoma tumor
cells
Common Adverse Pruritus (69%), skin rash (83%), decreased serum PO 4 (51%), increased serum glucose (66%),
Events (≥50%) decreased absolute lymphocyte count (91%; grades 3/4: 56%), decreased Hgb (51%), increased
serum ALT (≤65%), increased AST (≤65%), cytokine release syndrome (89%), fatigue (64%),
increased serum Cr (87%), fever (76%)
Dosage Forms​ Intravenous solution
Novel Attributes First-in-Class
Breakthrough Therapy
Cost (WAC) 100 mcg/0.5 ml solution: $18760.00 per 0.5 mL vial

Tebentafusp-tebn. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated October 11, 2022. Accessed January 10, 2023. https://online.lexi.com
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
Melanoma: uveal. National Comprehensive Cancer Network. Updated April 5, 2022. Accessed January 10, 2023.
 Pluvicto®
lutetium (Lu-177) vipivotide tetraxetan
Approval Date​ 3/23/2022 PRIORITY; Type 1-New Molecular Entity
Indication​ To treat prostate-specific membrane antigen-positive metastatic castration-resistant
prostate cancer following at least two other therapies
Class​ Radiopharmaceutical
Mechanism of Action Delivers radiation through beta-minus emission to the PSMA-expressing cells (a
transmembrane glutamate carboxypeptidase that is highly expressed on prostate cancer
cells), resulting in DNA damage and cell death
Common Adverse Events Decreased serum Ca, increased/decreased serum Na, increased serum K, weight loss,
(>10%) abdominal pain, constipation, decreased appetite, diarrhea, nausea, vomiting,
xerostomia, urinary tract infection, anemia, decreased neutrophils, leukopenia,
lymphocytopenia, thrombocytopenia, increased serum AST, fatigue, increased serum Cr
Dosage Forms​ Intravenous solution
Novel Attributes First-in-Class
Breakthrough Therapy
Cost (WAC) 27 mci/1 ml solution: $42500.00 per vial

Lutetium (Lu-177) vipivotide tetraxetan. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated June 2, 2022. Accessed June 6, 2022. https://online.lexi.com
Lutetium Lu-177 vipivotide tetraxetan. DrugBank. March 24, 2022. Updated December 1, 2022. Accessed January 10, 2023.
https://go.drugbank.com/drugs/DB16778
FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Imjudo®
tremelimumab (TRE-me-LIM-ue-mab)
Approval Date​ 10/21/2022 Orphan

Indication​ Treat unresectable hepatocellular carcinoma (when combined with Imfinzi®

[durvalumab]) and metastatic non-small cell lung cancer

Class​ Anti-CTLA4 monoclonal antibody, antineoplastic agent

Mechanism of Action Blocks human IgG2 monoclonal antibody and is a negative regulator of T-cell activity as
well as binds to CTLA-4 and blocks CD80 and CD86 interaction, resulting in inhibition of
T-cell activation

Common Adverse Events Pruritus, skin rash, decreased serum sodium, decreased serum glucose, hypothyroidism,
(>10%) abdominal pain, diarrhea, decreased platelet count, lymphocytopenia, increased serum
alanine aminotransferase, increased serum alkaline phosphatase, fatigue, fever

Dosage Forms​ Intravenous solution

Cost (WAC) 20 mg/1 mL solution: $39000.00 per 15 mL vial

Tremelimumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023. https://online.lexi.com
Tremelimumab. DrugBank. October 16, 2016. Updated December 1, 2022. Accessed January 11, 2023.
https://go.drugbank.com/drugs/DB11771 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Elahere®
mirvetuximab soravtansine-gynx (MIR-ve-TUX-i-mab-SOE-rav-TAN-seen)

Approval Date​ 11/14/2022 PRIORITY; Orphan

Indication​ Platinum-resistant ovarian cancer

Class​ Anti-folate receptor alpha, antineoplastic agent

Mechanism of Action Consists of folate receptor alpha (FR 𝛼) monoclonal antibody, anti-tublin agent DM4,
and linker that attaches DM4 to the mirvetuximab antibody, once bound to FR 𝛼, DM4
is released intracellularly disrupting the microtubule network resulting in cellular
apoptosis
Common Adverse Events (>10%) Decreased serum albumin, decreased serum K and Mg, abdominal distention and
pain, diarrhea, vomiting, decreased hemoglobin and neutrophils, increased serum
ALT
Dosage Forms​ Intravenous solution

Clinical Pearls First-in-Class

Cost (WAC) 5 mg/1 mL solution: $6220.00 (per 20 mL vial)

Mirvetuximab soravtansine. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023.
https://online.lexi.com FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Lunsumio®
mosunetuzumab-axgb (moe-SUN-e-TOOZ-ue-mab)

Approval Date​ 12/22/2022 PRIORITY; Orphan

Indication​ Relapsed or refractory follicular lymphoma

Class​ Anti-CD20, antineoplastic agent

Mechanism of Action Binds to the CD3 receptor on T-cells and CD20 on the surface of lymphoma cells
and B-lineage cells

Common Adverse Events (>10%) Edema, pruritus, skin rash, decreased serum magnesium, phosphate, and
potassium, decreased hemoglobin, decreased neutrophils and white blood cell
count

Dosage Forms​ Intravenous solution

Novel Attributes First-in-Class

Breakthrough Therapy

Cost (WAC) 1 mg/1 mL solution 1 mL vial: $594.06 per mL; 30 mL vial: $17821.78

Mosunetuzumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
Lunsumio. Package insert. Genentech Inc; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 13, 2023. https://www.micromedexsolutions.com/
 Krazati®
adagrasib

Approval Date​ 12/12/2022 Orphan; Type 1-New Molecular Entity

Indication​ Patients with non-small lung cancer with the KRAS G12C mutation

Class​ KRAS Inhibitor, Antineoplastic Agent

Mechanism of Action Irreversibly inhibits the mutant cysteine in KRAS G12C and the
mutant KRAS protein in its inactive state which prevents
downstream signaling and does not affect wild-type KRAS protein

Common Adverse Events Edema, prolonged QT interval, decreased serum album, decreased
(>10%) Mg and K, abdominal pain, constipation, diarrhea, nausea, vomiting,
decreased platelet count, lymphocytopenia, dizziness, and fatigue

Dosage Forms​ Tablet

Novel Attributes Breakthrough Therapy

Cost (WAC) 200 mg tablet: $19750.00 per 180 tablets ($109.72 per tablet)
Adagrasib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 13, 2023. https://online.lexi.com
Krazati. Package insert. Mirati Therapeutics Inc; 2022.
KRAS Gene. Medline Plus. Updated December 1, 2017. Accessed January 13, 2023.
Adagrasib. DrugBank. November 1 2019. Updated December 17, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15568 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 13, 2023. https://www.micromedexsolutions.com/
 Rezlidhia®
olutasidenib (oh-LOO-ta-SID-e-nib)

Approval Date​ 12/1/2022 Orphan; Type 1-New Molecular Entity

Indication​ Acute myeloid leukemia, relapsed or refractory, IDH1-mutated
Class​ Isocitrate dehydrogenase-1 (IDH1) inhibitor
Mechanism of Action Inhibits mutant IDH1 variants, prevents IDH1 mutations from increasing levels of 2-
hydroxyglutarate (2-HG) in leukemia cells, helps restore normal myeloid cell
differentiation
Common Adverse Events Skin rash (24%), decreased serum potassium (46%), decreased serum sodium (42%),
(>20%) increased uric acid (25%), constipation (26%), diarrhea (20%), increased serum lipase
(24%), nausea (38%), stomatitis (23%), leukocytosis (25%), lymphocytosis (26%),
increased serum alanine aminotransferase (46%), increased serum alkaline
phosphatase (42%), increased serum aspartate aminotransferase (47%), increased
serum bilirubin (26%), fatigue (≤36%), malaise (≤36%), arthralgia (28%), increased
serum creatinine (38%), dyspnea (24%), fever (24%)
Dosage Forms​ Oral capsule
Cost (WAC) 150 mg capsules: $16100.00 per 30 capsules ($536.67 per capsule)

Olutasidenib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 11, 2023. Accessed January 19, 2023. https://online.lexi.com
Rezlidhia. Package insert. Rigel Pharmaceuticals Inc.; 2022 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 19, 2023. https://www.micromedexsolutions.com/
 Lytgobi®
futibatinib (FUE-ti-BA-ti-nib)
Approval Date​ 9/30/2022 PRIORITY: Orphan; Type 1-New Molecular Entity
Indication​ Intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2)
gene fusions or other rearrangements
Class​ Fibroblast Growth Receptor (FGFR) inhibitor, Tyrosine Kinase Inhibitor
Mechanism of Action Binds to FGFR to prevent downstream signaling and decrease cell viability in cancer
cell lines
Common Adverse Events Nail disease (47%), decreased serum phosphate (50%), decreased serum Na (51%),
(>45%) increased serum Ca (51%), increased serum glucose (52%), increased serum
phosphate (97%), decrease hemoglobin (52%), lymphocytopenia (46%), increase ALT
(50%), increase serum alkaline phosphatase (47%), increase AST (46%), increased
serum creatinine (58%)
Dosage Forms​ Tablet
Novel Attributes Breakthrough Therapy
Cost (WAC) 4 mg tablets: $5835.00 per 21, 28, and 35 tablets (21 tablets: $277.86 / 28 tablets:
$208.39 / 35 tablets: $166.71

Futibatinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 18, 2023. Accessed January 20, 2023. https://online.lexi.com
Lytgobi. Package insert. Taiho Pharmaceutical Co; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 20, 2023. https://www.micromedexsolutions.com/
 Tecvayli®
teclistamab-cqyv
Approval Date​ 10/25/2022 PRIORITY; Orphan
Indication​ Multiple, refractory, or relapsed myeloma in adult patients who received at least 4
prior therapies
Class​ Antineoplastic agent, monoclonal antibody
Mechanism of Action T-cell antibody that binds to CD3 receptors on T and B-cell maturation antigen and
causes release of various proinflammatory cytokines that leads to lysis of multiple
myeloma cells
Common Adverse Events (>10%) Hypertension, hypotension, edema, cardiac arrhythmia, decreased serum albumin,
calcium, phosphate and sodium, constipation, urinary tract infection, cytokine
release syndrome
Dosage Forms​ Subcutaneous solution
Novel Attributes First-in-Class
Breakthrough Therapy
Cost (WAC) 10 mg/1 mL solution 3 mL vials: $1770.00 per vial
90 mg/1 mL solution 1.7 mL vials: $9027.00 per vial

Teclistamab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 17, 2023. Accessed January 20, 2023. https://online.lexi.com
Tecvayli. Package insert. Janssen Pharmaceutical Companies; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 20, 2023. https://www.micromedexsolutions.com/
 Rolvedon®
eflapegrastim (EF-la-PEG-ra-stim)

Approval Date​ 9/9/2022

Indication​ Prevent chemotherapy-induced neutropenia to reduce incidence of infection in

patients receiving myelosuppressive anticancer drugs

Class​ Hematopoietic agent, colony stimulating factor

Mechanism of Action Binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering
the signaling pathways for cell differentiation, proliferation, migration and survival

Common Adverse Events (>10%) Peripheral edema, skin rash, abdominal pain, anemia, thrombocytopenia,
arthralgia, myalgia, ostealgia, fever, dyspnea, cough

Dosage Forms​ Solution, single-dose subcutaneous injection

Cost (WAC) 13.2 mg/0.6 mL solution 0.6 mL syringes: $4500.00 per syringe

Eflapegrastim. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 20, 2023. Accessed January 20, 2023. https://online.lexi.com
Rolvedon. Package insert. Spectrum Pharmaceuticals; 2022. FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 20. 2023. https://www.micromedexsolutions.com/
 Vonjo®
pacritinib (pak-RI-ti-nib)
Approval Date​ 2/28/2022 PRIORITY; Orphan; Type 1-New Molecular Entity

Indication​ To treat intermediate or high-risk primary or secondary myelofibrosis in adults

with low platelets
Class​ Janus Associated Kinase/Tyrosine Kinase Inhibitor

Mechanism of Action Kinase inhibitor selective for JAK2, suppressing the interleukin-1 directed
inflammatory pathway through interleukin 1 receptor associated kinase 1 (IRAK1)
inhibition, abnormal JAK2 activation is associated with myeloproliferative
neoplasms
Common Adverse Events (>10%) Peripheral edema, diarrhea, nausea, vomiting, anemia, hemorrhage,
thrombocytopenia, dizziness, epistaxis, fever

Dosage Forms​ Oral capsule

Cost (WAC) 100 mg: $23,550.00 for 120 capsules ($196.25 per capsules)

Pacritinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Question 4

Which of the following agents, according to the NCCN, is

considered a first-line option for metastatic cutaneous
melanoma?
a. nivolumab and relatimab-rmbw
b. pacritinib
c. abrocitinib
d. oteseconazole

Objective 4: Discuss the potential role of these newly approved drugs in current pharmacy practice

FROM HERE TO ANYWHERE

Imaging

FROM HERE TO ANYWHERE

 Elucirem®
gadopiclenol
Approval Date​ 9/21/2022 PRIORITY; Type 1-New Molecular Entity and Type 4-
New Combination
Indication​ Used during MRI imaging to visualize lesions in the head, neck,
brain, spine, thorax, abdomen, pelvis, and musculoskeletal
systems in adults and pediatric patients (>2 years old)

Class​ Diagnostic agent, contrast media

Mechanism of Action Relaxes water protons in the body to increase brightness of tissues
due to it’s paramagnetic structure that creates a magnetic moment
when placed in a magnetic field

Common Adverse Allergic dermatitis, pruritus, diarrhea, nausea, vomiting, dizziness,

Events (<1%) headache

Dosage Forms​ Intravenous solution

Cost (WAC) Not available

Gadopclenol. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 30, 2022. Accessed January 11, 2023. https://online.lexi.com
Gadopiclenol. DrugBank. November 2, 2012. Updated December 1, 2022. Accessed January 11, 2023.
https://go.drugbank.com/drugs/DB17084 FROM HERE TO ANYWHERE
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/
 Xenoview®
hyperpolarized Xe-129

Approval Date​ 12/23/2022 Type 1-New Molecular Entity

Indication​ Evaluate pulmonary function and imaging in patients >12 years old

Class​ Diagnostic agent, imaging

Mechanism of Action Hyperpolarized xenon (Xe-129) nuclei are detected by the MRI scanner to
provide pulmonary imaging
Common Adverse Events (1-10%) Dizziness, headache, oropharyngeal pain

Dosage Forms​ Gas (inhaled)

Novel Attributes First-in-Class

Cost (WAC) Not available

Xenon Xe 129 Hyperpolarized. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023.
https://online.lexi.com
Xenon Xe-129. DrugBank. January 3, 2023. Updated January 11, 2023. Accessed January 11, 2023. https://go.drugbank.com/drugs/DB17386
IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 10, 2023. https://www.micromedexsolutions.com/ FROM HERE TO ANYWHERE
 2023 Approvals From the FDA

Leqembi® (lecanemab-irmb)
• Treatment of Alzheimer’s disease

Brenzavvy® (bexagliflozin)
• Improvement of glycemic control in adults with T2DM in combination with diet and exercise

Jayprica® (tobrutinib)
• Treatment of relapsed/refractory mantle cell lymphoma in adults who have had at least two lines of systemic
therapy, including a BTK inhibitor
Orserdu® (elacestrant)
• Treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated,
advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
Jesduvroq® (daprodustat)
• Treatment of anemia cause by chronic kidney disease in adults on dialysis for at least four months

Novel drug approvals for 2023. U.S. Food & Drug Administration (FDA). Updated February 2, 2023. Accessed February 3, 2023. https:// FROM HERE TO ANYWHERE
www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023
 References
1. Novel Drug Approvals for 2022. U.S. Food and Drug Administration. Updated January 10, 2023. Accessed January 9, 2023.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022
2. IBM Micromedex Red Book. IBM Watson Health; 2023. Accessed January 9, 2023. https://www.micromedexsolutions.com/
3. Drugs@FDA: FDA-approved drugs. US. Food & Drug Administration. Accessed January 24, 2023. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
4. New Drug Therapy Approvals 2022. Center for Drug Evaluation and Research. Updated January 2023. Accessed January 24, 2023. https://www.fda.gov/media/164429/download
5. Tapinarof. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 4, 2022. Accessed January 10, 2023. https://online.lexi.com
6. Tapinarof. DrugBank. November 18, 2007. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB06083
7. Deucravacitinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
8. Deucravacitinib. DrugBank. March 24, 2021. Updated December 6, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB16650
9. Sotyktu. Package insert. Bristol-Myers Squibb Company; 2022.
10. Spevigo. Package insert. Boehringer Ingelheim Pharmaceuticals; 2022.
11. Spesolimab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
12. Abrocitinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
13. Anacaulase. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 13, 2023. https://online.lexi.com
14. NexoBrid. Package insert. MediWound; 2022.
15. DaxibotulinumtoixnA. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 5, 2022. Accessed January 17, 2023. https://online.lexi.com
16. Daxxify. Package insert. Revance Therapeutics Inc; 2022.
17. Daridorexant. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 11, 2022. Accessed January 9, 2023. https://online.lexi.com
18. Quviviq. Package insert. Idorsia Pharmaceuticals; 2022.
19. Ganaxolone. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 28, 2022. Accessed January 10, 2023. https://online.lexi.com
20. Ganaxolone. DrugBank. October 21, 2007. Updated April 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB05087
21. Ublituximab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
22. Briumvi. Package insert. TG Therapeutics; 2022.
23. Vutrisiran. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 3, 2022. Accessed January 19, 2023. https://online.lexi.com
24. Amvuttra. Package insert. Alnylam Pharmaceuticals, Inc.; 2022.
25. Sodium phenylbutyrate/taurursodiol. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 14, 2023. Accessed January 19,2023. https://online.lexi.com
26. Relyviro. Package insert. Amylyx Pharmaceuticals Inc.; 2022.
27. Oomidenepag isopropyl. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 11, 2022. Accessed January 13, 2023. https://online.lexi.com
28. Omlonti. Package insert. Santen Incorporated; 2022.
29. Oomidenepag isopropyl. DrugBank. May 20, 2019. Updated December 1, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15071
30. Faricimab-svoa. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 2, 2022. Accessed January 10, 2023. https://online.lexi.com
31. Tirzepatide. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 30, 2022. Accessed January 10, 2023. https://online.lexi.com
32. Tirzepatide. DrugBank. May 20, 2019. Updated December 23, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB15171
33. Teplizumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 19, 2023. Accessed January 19, 2023. https://online.lexi.com
34. Tzield. Package insert. Provention Bio, Inc.; 2022.
35. Mavacamten. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022. Accessed January 10, 2023. https://online.lexi.com
36. Mavacamten. DrugBank. May 20, 2019. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB14921
37. Mitapivat. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2021. Updated May 18, 2022. Accessed June 6, 2022. https://online.lexi.com
38. Mitapivat. DrugBank. December 15, 2022. Updated March 8, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB16236
39. Sutimlimab-jome. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
40. Olipudase alfa. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022. Accessed January 17, 2023. https://online.lexi.com
41. Xenpozyme. Package insert. Genzyme Corporation; 2022.
42. Terlipressin. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated November 30, 2022. Accessed January 17, 2023. https://online.lexi.com
43. Terlivaz. Package insert. Mallinckrodt; 2022.

FROM HERE TO ANYWHERE

 References
44. Vonoprazan. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 17, 2022. Accessed January 10, 2023. https://online.lexi.com
45. Voquezna. Package insert. Phathom Pharmaceuticals, Inc.; 2022.
46. Vonoprazan DrugBank. October 20, 2016. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB11739
47. Oteseconazole. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 5, 2022. Accessed January 10, 2023. https://online.lexi.com
48. Oteseconazole. DrugBank. October 21, 2016. Updated May 3, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB13055
48. Lenacapavir. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
49. Capsid Inhibitor(s). Clinical Info HIV. Accessed January 13, 2023. https://clinicalinfo.hiv.gov/en/glossary/capsid-inhibitors
50. Lenacapavir. DrugBank. April 20, 2020. Updated December 31, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15673
51. Sunlenca. Package insert. Gilead Sciences; 2022.
52. Lenacapavir. DrugBank. April 20, 2020. Updated December 31, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15673
53. Sunlenca. Package insert. Gilead Sciences; 2022.
54. Nivolumab and Relatlimab-rmbw. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 19, 2022. Accessed January 10, 2023. https://online.lexi.com
55. Melanoma: cutaneous. National Comprehensive Cancer Network. Updated December 22, 2022. Accessed January 10, 2023.
56. Tebentafusp-tebn. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated October 11, 2022. Accessed January 10, 2023. https://online.lexi.com
57. Melanoma: uveal. National Comprehensive Cancer Network. Updated April 5, 2022. Accessed January 10, 2023.
58. Lutetium (Lu-177) vipivotide tetraxetan. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated June 2, 2022. Accessed June 6, 2022. https://online.lexi.com
59. Lutetium Lu-177 vipivotide tetraxetan. DrugBank. March 24, 2022. Updated December 1, 2022. Accessed January 10, 2023. https://go.drugbank.com/drugs/DB16778
60. Tremelimumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023. https://online.lexi.com
61. Tremelimumab. DrugBank. October 16, 2016. Updated December 1, 2022. Accessed January 11, 2023. https://go.drugbank.com/drugs/DB11771
62. Mirvetuximab soravtansine. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023. https://online.lexi.com
63. Mosunetuzumab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 13, 2023. Accessed January 13, 2023. https://online.lexi.com
64. Lunsumio. Package insert. Genentech Inc; 2022.
65. Adagrasib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 13, 2023. https://online.lexi.com
66. Krazati. Package insert. Mirati Therapeutics Inc; 2022.
67. KRAS Gene. Medline Plus. Updated December 1, 2017. Accessed January 13, 2023.
68. Adagrasib. DrugBank. November 1, 2019. Updated December 17, 2022. Accessed January 13, 2023. https://go.drugbank.com/drugs/DB15568
69. Rezlidhia. Package insert. Rigel Pharmaceuticals Inc.; 2022.
70. Olutasidenib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 11, 2023. Accessed January 19, 2023. https://online.lexi.com
71. Futibatinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 18, 2023. Accessed January 20, 2023. https://online.lexi.com
72. Lytgobi. Package insert. Taiho Pharmaceutical Co; 2022.
73. Teclistamab. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 17, 2023. Accessed January 20, 2023. https://online.lexi.com
74. Tecvayli. Package insert. Janssen Pharmaceutical Companies; 2022.
75. Eflapegrastim. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 20, 2023. Accessed January 20, 2023. https://online.lexi.com
76. Rolvedon. Package insert. Spectrum Pharmaceuticals; 2022.
77. Pacritinib. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 5, 2023. Accessed January 10, 2023. https://online.lexi.com
78. Gadopclenol. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated December 30, 2022. Accessed January 11, 2023. https://online.lexi.com
79. Gadopiclenol. DrugBank. November 2, 2012. Updated December 1, 2022. Accessed January 11, 2023. https://go.drugbank.com/drugs/DB17084
80. Xenon Xe 129 Hyperpolarized. Lexi-Drugs. Lexicomp. UpToDate, Inc.; 2023. Updated January 9, 2023. Accessed January 11, 2023. https://online.lexi.com
81. Xenon Xe-129. DrugBank. January 3, 2023. Updated January 11, 2023. Accessed January 11, 2023. https://go.drugbank.com/drugs/DB17386
82. Novel drug approvals for 2023. U.S. Food & Drug Administration (FDA). Updated February 2, 2023. Accessed February 3, 2023.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023

FROM HERE TO ANYWHERE

 Thank you!

Contact us if you have any questions

samuel.hwang@belmont.edu
samantha.triplett@belmont.edu

FROM HERE TO ANYWHERE