Posted by Michael Wonder on 09 Aug 2023
FDA approves pralsetinib for non-small-cell lung cancer with RET gene fusions
9 August 2023 - Today, 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 as detected by an FDA approved test.
Pralsetinib was previously granted accelerated approval for the non-small-cell lung cancer indication on 4 September 2020, based on initial overall response rate and duration of response in 114 patients enrolled in the ARROW trial, a multi-center, open-label, multi-cohort trial.
