FDA Grants Traditional Approval to Retevmo (selpercatinib) for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors, Expanding Patient Access

July 19, 2026

FDA USA

Overview

On July 14, 2026, the FDA granted traditional approval to Eli Lilly and Company’s Retevmo (selpercatinib) for patients aged two years and older with locally advanced or metastatic RET fusion-positive solid tumors that have progressed on prior systemic treatment or have no satisfactory alternative options. This decision expands upon its previous accelerated approvals in 2022 for adults and 2024 for pediatric patients, solidifying the drug’s established efficacy and safety in treating RET fusion cancers.

In Depth

Key Findings

On July 14, 2026, the U.S. Food and Drug Administration (FDA) granted traditional approval to Retevmo (selpercatinib), a selective RET inhibitor manufactured by Eli Lilly and Company, for patients with locally advanced or metastatic RET fusion-positive solid tumors. This expanded approval covers adult and pediatric patients aged two years and older who have experienced disease progression on prior systemic treatment or possess no satisfactory alternative therapeutic options.

Technical & Clinical Details

Selpercatinib is a small-molecule tyrosine kinase inhibitor (TKI) that specifically targets rearrangements during transfection (RET) fusion gene alterations. RET fusions are recognized as oncogenic driver mutations in various solid tumors, including thyroid cancer, lung cancer, and other malignancies. The traditional approval was based on comprehensive data from pivotal multi-center, international clinical trials, such as the LIBRETTO-001 study. These trials demonstrated compelling objective response rates (ORR) and durable response durations (DOR) in patients with RET fusion-positive solid tumors. The safety profile remained consistent and manageable, confirming the drug’s overall tolerability as observed during its initial accelerated approvals.

Background & Context

RET fusion-positive solid tumors are rare cancers driven by specific molecular alterations, and historically, standard treatment options have been limited. Selpercatinib previously received accelerated approval in 2022 for adult patients and in 2024 for pediatric patients aged two years and older, acknowledging its promising efficacy. The conversion to traditional approval signifies that additional confirmatory data has established the sustained clinical benefit and safety of selpercatinib across a broader patient population. This solidifies its position as a standard of care for RET fusion-positive cancers.

Strategic Significance & Outlook

The traditional approval of Retevmo marks a significant therapeutic advance for adult and pediatric patients with RET fusion-positive solid tumors. It ensures broader access to a targeted therapy that offers the potential for effective disease control and improved quality of life. Furthermore, this success is expected to further catalyze the development of precision medicines for other cancers driven by rare molecular alterations. Future investigations may explore the drug’s potential utility in other RET alterations, including non-fusion RET aberrations, and other solid tumor types.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive

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