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NCCN Guidelines for Thyroid Carcinoma V.3.

2020 – Interim on 12/21/20

Guideline Page Institution Vote


Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
PAP-10, PAP-11, FOLL-8, FOLL-9, HURT-8, HURT-9 Based on the review of the data in the noted 17 1 5 7
Internal request: references and the FDA approval, the panel
In response to the FDA approval of pralsetinib consensus was to include pralsetinib as an option for
for adult and pediatric patients 12 years of age and patients with RET-fusion positive papillary carcinoma,
older with advanced or metastatic RET fusion positive follicular carcinoma, or Hürthle Cell Carcinoma who
thyroid cancer who require systemic therapy and who have structurally persistent/recurrent locoregional or
are radioactive iodine-refractory (if radioactive iodine is metastatic disease not amenable to radioactive
appropriate). iodine therapy. The Panel consensus supported a
category 2A systemic therapy option.
External request from BluePrint Medicines Corp.
(12/1/20) to include pralsetinib as a treatment option See Submission for References.
for:
• Adult and pediatric patients 12 years of age and older
with advanced or metastatic RET fusion-positive
thyroid cancer who require systemic therapy and who
are radioactive iodine-refractory (if radioactive iodine is
appropriate).
MEDU-6 and MEDU-7 Based on the review of the data in the noted 18 1 4 7
Internal request: references and the FDA approval, the panel
In response to the FDA approval of pralsetinib consensus was to include pralsetinib as an option for
for adult and pediatric patients 12 years of age and patients with RET-mutation positive medullary
older with advanced or metastatic RET-mutant carcinoma who have recurrent or persistent
medullary thyroid cancer (MTC) who require systemic locoregional or distantly metastatic disease. The
therapy. Panel consensus supported a category 2A, preferred
systemic therapy option.
External request from BluePrint Medicines Corp.
(12/1/20) to include pralsetinib as a treatment option See Submission for References.
for:
• Adult and pediatric patients 12 years of age and older
with advanced or metastatic RET-mutant medullary
thyroid cancer (MTC) who require systemic therapy

ANAP-2 and ANAP-A Based on the review of the data in the noted 15 1 5 9
Internal request: references and the FDA approval, the panel
In response to the FDA approval of pralsetinib consensus was to include pralsetinib as an option for
for adult and pediatric patients 12 years of age and patients with metastatic RET-fusion positive
older with advanced or metastatic RET fusion positive anaplastic carcinoma. The Panel consensus
thyroid cancer who require systemic therapy and who supported a category 2A, preferred systemic therapy
option.
NCCN Guidelines for Thyroid Carcinoma V.3.2020 – Interim on 12/21/20

are radioactive iodine-refractory (if radioactive iodine is


appropriate). The Panel also supported the inclusion of pralsetinib
to footnote “g” with the reference: Subbiah et al.
External request from BluePrint Medicines Corp. Clinical activity of the RET inhibitor pralsetinib (BLU-
(12/1/20) to include pralsetinib as a treatment option 667) in patients with RET fusion positive solid tumors.
for: Presented at the American Society of Clinical
• Adult and pediatric patients 12 years of age and older Oncology (ASCO) Annual Meeting; May 29-31,
with advanced or metastatic RET fusion-positive 2020).
thyroid cancer who require systemic therapy and who
are radioactive iodine-refractory (if radioactive iodine is See Submission for References.
appropriate).

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