FDA approves Gavreto for metastatic RET fusion-positive NSCLC

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December 2020—Roche announced FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection fusion–positive non-small cell lung cancer 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.

Approval is based on the results from the phase one/two 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.