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

The FDA has granted traditional approval to selpercatinib (Retevmo, Lilly) 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 builds on previous positive findings in non–small cell lung cancer and thyroid cancer, with recent results from the LIBRETTO-001 trial demonstrating efficacy in other solid tumors with a RET gene fusion.