Skip to main content

Pralsetinib Approved for Non–Small Cell Lung Cancer With RET Gene Fusions

The FDA has granted regular approval to pralsetinib (Gavreto®, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. Previously, pralsetinib was granted accelerated approval for the NSCLC indication on September 4, 2020, based on the initial overall response rate and duration of response findings in 114 patients. Based on data of the addition of 123 patients and 25 months of...

Continue reading