FDA Approval Insights: Selpercatinib in RET Fusion–Positive Solid Tumors


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Dr Subbiah discusses the significance of the FDA approval of selpercatinib in RET fusion–positive non–small cell lung cancer, thyroid cancer, and other solid tumors.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Vivek Subbiah, MD, an associate professor in the Investigational Cancer Therapeutics Department and the clinical medical director of the Clinical Center for Targeted Therapy in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Dr Subbiah joined us to talk about selpercatinib (Retevmo) in RET fusion–positive non–small cell lung cancer (NSCLC), thyroid cancer, and other solid tumors.

On September 21, 2022, the FDA granted regular approval to selpercatinib in adults with locally advanced or metastatic NSCLC harboring a RET gene fusion. In addition, the FDA gave accelerated approval to the agent in adults with locally advanced or metastatic solid tumors with a RET gene fusion who have progressed on or after prior systemic treatment or who have no other satisfactory treatment options. These regulatory decisions follow the May 2020 accelerated approval of selpercatinib in RET fusion–positive NSCLC, medullary thyroid cancer, and other thyroid cancers.

The approvals were based on findings from the phase 1/2 LIBRETTO-001 trial (NCT03157128), in which the agent elicited an overall response rate of 44% in all-comers, with 4.9% of patients achieving a complete response and 39% achieving a partial response.

In our exclusive interview, Dr Subbiah discussed the significance of these approvals across solid tumor types, key efficacy and safety data from LIBRETTO-001, and what the solid tumor treatment landscape will look like with selpercatinib in the armamentarium.


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