FDA Grants Retevmo Full Approval for RET Fusion-Positive Lung Cancer Treatment

The Food and Drug Administration (FDA) granted a regular approval to Retevmo (selpercatinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged RET gene fusion, as detected by the Oncomine DxTarget test, which was also approved.

Retevmo was granted an accelerated approval in May 2020, based on findings from the LIBRETTO-001 trial which showed that the agent showed promising overall response rates (percentage of patients whose disease shrinks as a result of treatment) and duration of response.

Findings showed that the among the 79 patients in the trial who did not previously receive treatment, the overall response rate (percentage of patients with a partial or complete response to treatment) was 84%, and the average duration of response (the time the disease responds to a treatment without growth or spread) was 20.2 months.

There were also 247 patients who were previously treated with a platinum-based chemotherapy regimen. In this group, the overall response rate was 61%, with average duration of response 28.6 months.

The most common side effect from Retevmo that occurred in 25% or more of patients were: swelling, diarrhea, fatigue, dry mouth, high blood pressure, abdominal pain, constipation, rash, nausea and headache.

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