FDA Grants Traditional Approval to Selpercatinib for RET Fusion-Positive Solid Tumors

The U.S. Food and Drug Administration (FDA) has granted traditional approval to selpercatinib (Retevmo) for the treatment of locally advanced or metastatic RET fusion-positive solid tumors in patients aged 2 years and older who have received prior systemic treatment. This approval, based on findings from the LIBRETTO-001 trial, demonstrates the drug's efficacy across various tumor types beyond non-small cell lung cancer and thyroid cancer.