Clin Cancer Res. 2021 May 27:clincanres.0967.2021. doi: 10.1158/1078-0432.CCR-21-0967. Online ahead of print.
ABSTRACT
The FDA granted accelerated approval for pralsetinib on September 4 for NSCLC and December 1, 2020 for thyroid cancer, for: 1) adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), 2) adult and pediatric patients {greater than or equal to}12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (M TC) who require systemic therapy, and 3) adult and pediatric patients {greater than or equal to}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). Approval was based on the results of a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385), demonstrating substantial overall response rates (ORR) and durable responses in patients with RET-altered tumors. ORRs within the approved patient populations ranged from 57% (95% CI: 46, 68) in patients with RET fusion-positive NSCLC previously treated with platinum chemotherapy to 89% (95% CI: 52, 100) in patients with RET fusion-positive thyroid cancer, with response duration of at least 6 months in most responders. The product label includes warnings and precautions for pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, tumor lysis syndrome, risk of impaired wound healing, and embryo-fetal toxicity. This article summarizes the major considerations during the FDA review leading to the approval of pralsetinib.
PMID:34045295 | DOI:10.1158/1078-0432.CCR-21-0967
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