Eli Lilly’s Retevmo Gains FDA Approval for Two Indications

September 23, 2022

Eli Lilly’s Retevmo (selpercatinib) has received regular approval from the FDA for adult patients with locally advanced or metastatic nonsmall-cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.

The kinase inhibitor drug was previously granted an accelerated approval for the NSCLC indication in May 2020. The conversion to regular approval was supported by additional data on the durability of response.

The FDA has also granted the drug an accelerated approval for adult patients with locally advanced or metastatic solid tumors with a RET gene fusion — when a piece of DNA joins with another gene and leads to uncontrolled cell growth — that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

The accelerated approval for this indication was supported by an overall response rate of 44 percent and a duration of response of 24.5 months. Continued approval will require verification of the clinical benefit in confirmatory trials, the agency said.

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