Blueprint Medicines’ Gavreto Approved for Non-Small Cell Lung Cancer

The FDA has approved Blueprint Medicines’ Gavreto (pralsetinib) for adults with metastatic rearranged during transfection (RET), fusion-positive non-small cell lung cancer.

The accelerated approval was based on a phase 1/2 clinical trial, in which Gavreto demonstrated an overall response rate of 57 percent among patients previously treated with chemotherapy, with 5.7 percent achieving a complete response. In addition, 70 percent of patients who were not previously treated achieved a response, with 11 percent achieving a complete response.

Massachusetts-based Blueprint Medicines and Genentech will co-commercialize Gavreto in the U.S. Roche, Genentech’s parent company, will commercialize the product outside of the U.S., excluding China.