The FDA granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Pralsetinib was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial overall response rate (ORR) and duration of response (DOR) in 114 patients enrolled in the ARROW trial, a multicenter, open-label, multiple-cohort trial.
AUGUST 10, 2023