For Immediate Release

Government funds first-of-its-kind

blood cancer fighting medicine

Sydney, Australia 28 December, 2020 - Federal Government funding for a

first-in- class medicine to treat a common and deadly form of blood cancer,
multiple myeloma, by activating the patient’s immune system to identify and kill
cancer cells,1-4 is being welcomed by medical experts, patients and the Janssen
Pharmaceutical Companies of Johnson & Johnson.

From 1 January 2021, Darzalex® (daratumumab) will become available on the

Pharmaceutical Benefits Scheme (PBS) for Australians with multiple myeloma
whose disease progresses after initial treatment. It will be used in combination
with existing medicines, bortezomib and dexamethasone, after one prior line of
treatment.5,6

Darzalex will be the first new type of medicine for multiple myeloma to be added
to the PBS in more than a decade.5-7 It is a targeted therapy that works by
attaching to a specific protein on the surface of a multiple myeloma cell, and by
doing so triggers the patient’s immune system to attack and destroy multiple
myeloma cancer cells.1-4

An estimated 1,000 Australians will be eligible for treatment with Darzalex each
year8. Eligible patients will now pay $41.30 (general patients) or $6.60
(concessional patients) for each phase of treatment*.9

Multiple myeloma is an incurable blood cancer that affects plasma cells found in
the bone marrow.10 More than 2,000 new cases of multiple myeloma are expected
to be diagnosed in Australia this year and approximately 1,000 people will lose
their lives to the disease.11

Professor Andrew Spencer, Head of the Malignant Haematology & Stem Cell
Transplantation Service at The Alfred Hospital in Melbourne, and one of the
doctors involved in Australian clinical trials of Darzalex, welcomed the new
subsidy, citing the serious need for new medicines to combat multiple myeloma.12

“Multiple myeloma is a very challenging cancer to treat. It is associated with high

rates of relapse, treatment resistance, and poor prognosis,”11-13 he said.

“After years of research, we now have an entirely new type of treatment to

suppress the cancer during a critical window - when a patient no longer responds
to initial treatment or their cancer returns after initial treatment,” 1-5 he said.

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“Myeloma becomes progressively harder to treat after each relapse.12-14 The PBS
subsidy only applies after a patient has had one prior line of treatment, giving
patients access to Darzalex early in their disease course.”5,6

Professor H. Miles Prince AO, Director of Molecular Oncology and Cancer

Immunology, Epworth Healthcare and of the Centre for Blood Cell Therapies at the
Peter MacCallum Cancer Centre, explained that the five-year survival rate for
people with multiple myeloma is just 51 per cent11 meaning “approximately one in
two patients will die within five years of their diagnosis”.

“Darzalex is a novel medicine that targets the Achilles’ heel of the myeloma cancer
cell, while simultaneously activating the body’s immune system to attack the
cancer,” 1-4 he said.

“This is the first time we have been able to directly target myeloma cancer cells,
while also putting the immune system to work against the cancer.”1-4

According to Myeloma Australia CEO, Steve Roach, Darzalex represents “the first
major development in the way multiple myeloma is treated in more than 10
years”.7

“Multiple myeloma claims the lives of far too many Australians. Patients and their
families understand this reality. The PBS listing of Darzalex means access to a
much-needed treatment without financial burden for eligible patients. This is a
major milestone that will be warmly welcomed across the country,” he said.

Bruce Goodwin, Managing Director, Janssen Australia and New Zealand, said: “Our
company has a long and proud history in the treatment of multiple myeloma. The
PBS listing of Darzalex gives doctors and patients a new way to fight this less
common and deadly form of blood cancer”.

“The Federal Government is to be commended for its significant investment in

making important new medicines like Darzalex accessible to Australians in need,”
he said.

Darzalex was first approved in 2017.1 More than 1,000 Australians have been
treated with Darzalex.8

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects plasma cells found in
the bone marrow. Myeloma affects multiple (hence ‘multiple myeloma’) places in
the body where bone marrow is normally active in adults, including within the
bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and
hips.10

As the cancer cells grow and spread, they can lead to bone pain and breakages,
frequent infections, kidney damage and anaemia.10

The disease has a poor prognosis and each year claims around 1,000 Australian
lives.11 Multiple myeloma is characterised by high rates of relapse,10 even if initial
treatment results in remission. Typically, the cancer becomes more aggressive
and more challenging to treat following each relapse.12,13
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About Darzalex
Darzalex is a first-in-class immunotherapy known as a CD38-directed monoclonal
antibody.1,2 The therapy works by binding to CD38, a signalling molecule on the
surface of multiple myeloma cells. In doing so, Darzalex triggers the patient’s
immune system to attack cancer cells, resulting in tumour cell death.1-4

Based on extensive research, Darzalex is indicated for the treatment of multiple

myeloma either alone or in combination with other therapies at various stages of
the disease.1,2 Darzalex will become available through the PBS for treatment in
combination with bortezomib and dexamethasone for patients with multiple
myeloma after one prior line of treatment.5,6

Darzalex is administered by infusion – initially every week, then once every three
weeks and then monthly until the cancer progresses.1,2

All medicines may have side-effects. Darzalex may cause infusion-related

reactions and may increase the incidence of upper respiratory tract infections.
Other possible side effects observed when Darzalex is used in combination with
bortezomib and dexamethasone are decreases in blood cell counts, peripheral
sensory neuropathy, diarrhoea, cough, fatigue, constipation, and back pain.1,2,14

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the
Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that
future a reality for patients everywhere by fighting sickness with science,
improving access with ingenuity, and healing hopelessness with heart. We focus
on areas of medicine where we can make the biggest difference: Cardiovascular
& Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience,
Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/australia. Follow on Twitter @JanssenANZ.

Janssen-Cilag Pty Ltd is part of the Janssen Pharmaceutical Companies of
Johnson & Johnson.

*Note to editors:
Treatment phase cost:
• one co-payment ($41.30 or $6.60) for the first 9 infusions over the first 9
weeks of treatment;
• one co-payment ($41.30 or $6.60) for the next 5 infusions over the next 15
weeks of treatment; followed by
• one co-payment ($41.30 or $6.60) for every 6 infusions over 24 weeks of
treatment hereon
- Ends -

Issued by Ethical Strategies on behalf of Janssen Australia and New Zealand

(Janssen-Cilag Pty Ltd).

For further information please contact:

Rebecca Anable (0404 019 323) or Georgina Connery (0420 377 685) at
Ethical Strategies. Rita Corrente (0437 849 792) at Janssen Australia and
New Zealand.

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No compensation was provided to Professor Andrew Spencer, Professor Miles Prince or
Steve Roach for their involvement in this media activity, and the opinions expressed are
their own. The three individuals have been briefed by Janssen on the approved use of this
product and the Medicines Australia Code of Conduct. Professors Spencer and Prince have
served on advisory boards and been involved in clinical trials sponsored by Janssen for
which compensation was received.

Consumer Medicine Information is available at:

https://www.janssen.com/australia/sites/www_janssen_com_australia/files/prod_files/live
/darzalex_cmi.pdf

References:
1. Janssen-Cilag Pty Ltd. DARZALEX Product Information. September 2020.
2. Janssen-Cilag Pty Ltd. DARZALEX Consumer Medicine Information. September 2020.
3. Overdijk, M. et al. Antibody-mediated phagocytosis contributes to the anti-tumor
activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma,
MAbs, 2015;7(2):311-321.
4. de Weers, M. et al. Daratumumab, a novel therapeutic human CD38 monoclonal
antibody, induces killing of multiple myeloma and other hematological tumors. J
Immunol. 2011;186(3):1840- 1848.
5. Department of Health. Recommendations Made by the PBAC - July 2020. Available at:
https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-
outcomes/2020-07/positive-recommendations-07-2020.pdf
6. Department of Health. Schedule of Pharmaceutical Benefits. Available at:
http://www.pbs.gov.au/pbs/home
7. Department of Health. Public Summary Document Recommendations Made by the
PBAC – July 2007. Available at
https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/2007-
07/pbac-psd-bortezomib-july07
8. Janssen. Data on File. 2020.
9. Department of Health. Pharmaceutical Benefits: Fees, Patient Contributions and Safety
Net Thresholds. Available at: http://www.pbs.gov.au/info/healthpro/explanatory-
notes/front/fee
10. Myeloma Australia. What is Myeloma? Available at: https://myeloma.org.au/what-is-
myeloma/
11. Cancer Australia. Myeloma in Australia Statistics. 2020. Available at:
https://www.canceraustralia.gov.au/affected-cancer/cancer-types/myeloma-
cancer/statistics
12. Genadieva, S. et al. How is patient care for multiple myeloma advancing? Expert Rev
Hematol. 2017 Jun;10(6):551-561.
13. Zhao, J. et al. Real-world treatment patterns in relapsed/refractory multiple myeloma
in Australia: results from the Myeloma and Related Diseases Registry, BLOOD, Perth,
Australia, October 2019.
14. Mateos M.V. et al; Daratumumab, bortezomib and dexamethasone Versus bortezomib
and dexamethasone in patients with previously treated multiple myeloma: three-year
follow-up of CASTOR. Clinical Lymphoma, Myeloma & Leukaemia. 2020;20(8):509-
518

Janssen-Cilag Pty Ltd, ABN 47 000 129 975, 1-5 Khartoum Road, Macquarie Park NSW
2113. Ph: 1800 226 334. Prepared November 2020. CP -192232