FDA grants regular approval to pralsetinib for RET fusion-positive lung cancer

The FDA granted regular approval to pralsetinib for adults with metastatic RET fusion-positive non-small cell lung cancer detected by an FDA-approved test. The drug had received accelerated approval for the condition on Sept. 4, 2020. The FDA said the regular approval was based on data from an additional 123 patients and 25 months of additional follow-up.

In the trial, 237 patients with locally advanced or metastatic disease received pralsetinib until their disease progressed or side effects became unacceptable. Among 107 patients who had not received treatment, the overall response rate was 78%, and median duration of response was 13.4 months. Among 130 patients previously treated with platinum-based chemotherapy, the rates were 63% and 38.8 months, respectively. The FDA listed musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia and cough among the most common adverse reactions.