The Food and Drug Administration (FDA) has approved Gavreto (pralsetinib; Blueprint Medicines) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).

Gavreto is a kinase inhibitor indicated for the treatment of adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test. It is designed to selectively and potently target oncogenic RET alterations that drive many cancer types, including approximately 1 to 2 percent of patients with NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy. Gavreto was granted accelerated approval by the FDA; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Blueprint Medicines. Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer [ news release]. September 4, 2020. Available at: click here. Accessed September 9, 2020.