FDA regularly approves pralsetinib to treat lung cancer subgroups

The U.S. Food and Drug Administration (FDA)regularly approves pralsetinib (Pralsetinib) to treat certain patients with non-small cell lung cancer. This indication applies to adult patients with metastatic non-small cell lung cancer who have been found to carry RET gene fusions by an FDA-approved test.

The indication for platinib was approved on an accelerated basis in September 2020 based on initial data related to overall response and duration of response in the multicenter, open-label ARROW trial, which included patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer. The FDA converted accelerated approval to regular approval based on data from additional trial participants, plus an additional 25 months of follow-up to allow for additional assessment of durability of response.

237 trial participants received platinib until disease progression or unacceptable toxicity. Blinded Independent Review Committee ORR and duration of response were the primary efficacy endpoints. Analysis of 107 treatment-naive patients showed an ORR of 78% (95% confidence interval, 68-85) and a median duration of response of 13.4 months (95% confidence interval, 9.4-23.1). Analysis of 130 trial participants who had received prior platinum-based chemotherapy showed an ORR of 63% (95% confidence interval, 54 to 71) and a median duration of response of 38.8 months (95% confidence interval, 14.8 to not estimable).

The most common adverse reactions reported by at least 25% of trial participants included musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.