The FDA has converted selpercatinib (Retevmo), developed by Eli Lilly and Company, to traditional approval for adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion. The decision upgrades a prior accelerated approval, confirming clinical benefit for this tumor‑agnostic indication.
Selpercatinib is an oral, highly selective RET kinase inhibitor designed to block signaling driven by RET fusions and mutations, which act as oncogenic drivers across multiple cancer types. The traditional approval applies to adults whose RET fusion–positive tumors have progressed following prior systemic therapy or who lack satisfactory alternative treatment options.
The original accelerated approval was based on overall response rate and durability of response in patients enrolled in pivotal clinical trials, including those with non‑small cell lung cancer and various thyroid cancers. Additional follow‑up and expanded data sets supported sustained responses and manageable safety, meeting FDA requirements to transition to full approval.
Clinical studies have shown meaningful objective response rates and prolonged disease control in previously treated patients, reinforcing the role of targeted RET inhibition in precision oncology. Selpercatinib’s labeling includes safety warnings related to hepatotoxicity, hypertension, QT prolongation, hemorrhagic events, hypersensitivity, impaired wound healing, and embryo‑fetal toxicity, guiding monitoring and risk management in clinical use.
With this action, Eli Lilly’s selpercatinib remains a key option for patients with RET fusion–positive solid tumors, further establishing RET‑directed therapy as a standard targeted approach for this molecularly defined population.
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