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# Genentech’s Gavreto Approved for Lung Cancer
- URL: https://www.fdaweb.com/genentechs-gavreto-approved-for-lung-cancer/
- Published: 2020-09-08T12:00:00.000Z
- Updated: 2026-09-14T16:27:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147607

FDA has approved a Genentech NDA for Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations, the company says.

The accelerated approval was based on data from the Phase 1-2 ARROW study that demonstrated 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, Genentech says. Gavreto had an overall response rate (ORR) of 57% and a complete response rate of 5.7% in 87 people with NSCLC previously treated with platinum-based chemotherapy, it says. In the 27 people with treatment-naïve NSCLC, the ORR was 70% and 11% had a complete response. The company says that the most common adverse reactions (greater-than or equal to 25%) were fatigue, constipation, musculoskeletal pain and hypertension.