Pralsetinib Approved by FDA for Metastatic RET Fusion–Positive NSCLC
Posted: Tuesday, September 8, 2020
On September 4, the RET inhibitor pralsetinib (Gavreto) was approved by the U.S. Food and Drug Administration (FDA) in the treatment of adults with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. The companion diagnostic for pralsetinib—the Oncomine Dx Target Test—was also approved on September 4.
The approval was based on data from the open-label, multicohort phase I/II ARROW clinical trial. In this study, pralsetinib was found to be efficacious in the treatment of patients with RET fusion–positive NSCLC, with or without prior therapy and regardless of a RET fusion partner or involvement of the central nervous system. Of the 87 patients who were previously treated with platinum chemotherapy evaluated for efficacy in the ARROW trial, the overall response rate was 57% (95% confidence interval = 46%–68%); of the responding patients who had received prior treatment, 80% had responses lasting at least 6 months. Of the 27 patients who had never received systemic treatment, the overall response rate was 70% (95% confidence interval = 50%–86%); of the responding patients with no previous systemic treatment, 58% had responses lasting at least 6 months.
Pralsetinib has warnings and precautions about interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk of impaired wound healing, and risk of embryofetal toxicity. The recommended dose of pralsetinib is 400 mg orally once daily. It should be taken on an empty stomach.