Roche announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test, according to a press release.
Roche said this indication was approved under the FDA’s Accelerated Approval program, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. It is jointly marketed commercially by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the United States. It will be marketed by Roche outside of the United States, excluding Greater China.
RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and medullary thyroid cancer (MTC), and treatment options that selectively target these genetic alterations are limited. In NSCLC, RET fusions represent approximately 1-2 percent of patients.
Biomarker testing for these fusions is the most effective way to identify people who are eligible for treatment with Gavreto, according to Roche.
The approval is based on the results from the phase I/II ARROW study, in which Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement. Gavreto demonstrated an overall response rate (ORR) of 57 percent and complete response (CR) rate of 5.7 percent in the 87 people with NSCLC previously treated with platinum-based chemotherapy. In the 27 people with treatment-naïve NSCLC, the ORR was 70 percent, with an 11 percent CR rate.
Gavreto is now the sixth FDA-approved medicine in Roche’s portfolio of treatments for lung cancer.
The FDA has also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer.
