The FDA also granted priority review to pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
The FDA has approved pralsetinib (Gavreto, Genentech) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), a rare form of lung cancer affecting just 1% to 2% of patients with NSCLC.1
Pralsetinib is a once-daily oral precision therapy that selectively targets RET alterations, including fusions and mutations. These alterations are key in many cancer types, according to Genentech, and there are limited treatment options to selectively target these genetic fusions and mutations.
The FDA approval is based on results from the phase 1/2 ARROW study, which found durable responses among people with RET fusion-positive NSCLC with or without prior therapy when they received pralsetinib. Researchers also saw durable responses regardless of RET fusion partner or central nervous system involvement.
Pralsetinib demonstrated an overall response rate (ORR) of 57% and complete response rate (CRR) of 5.7% among the 87 participants with NSCLC who were previously treated with platinum-based chemotherapy. The median duration of response was not reached.
Among the 27 patients with treatment-naïve NSCLC, the ORR was 70% with an 11% CRR. The most common adverse reactions were fatigue, constipation, musculoskeletal pain, and increased blood pressure.
The approval was part of the accelerated approval program, and continued approval may be contingent on verification and description of the clinical benefit in confirmatory trials. The FDA also granted priority review to pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.