2021 FDA Registration Trials’ Reviews
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PEMBROLIZUMAB for adjuvant treatment of Stage IIB or IIC melanoma (3 Dec 2021)
REGULAR APPROVAL for “the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection.”
Based on the KEYNOTE-716 trial
1 - DESIGN:
2 - EFFICACY:
3 - TOXICITY:
Critical appraisal:
Overall conclusion:
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SELPERCATINIB for lung and thyroid cancers with RET gene mutations or fusions
ACCELERATED APPROVAL for “
- Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
- Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;
- Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).”