FDA Grants Regular Approval to Selpercatinib in Locally Advanced or Metastatic RET Fusion–Positive NSCLC

By: JNCCN 360 Staff
Posted: Thursday, September 22, 2022

Yesterday, the U.S. Food and Drug Administration (FDA) granted regular approval to the kinase inhibitor selpercatinib (Retevmo) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test. Also, the FDA approved the Oncomine Dx Target Test as a companion diagnostic for selpercatinib.

Selpercatinib was previously granted accelerated approval for the NSCLC indication in May 2020. It was based on initial overall response rate and duration of response in 144 patients enrolled in the LIBRETTO-001 trial (ClinicalTrials.gov identifier NCT03157128), a multicenter, open-label, multicohort trial. The conversion to regular approval was based on data from an additional 172 patients and 18 months of additional follow-up to assess the durability of response. Efficacy was demonstrated in a total of 316 patients with locally advanced or metastatic RET fusion–positive NSCLC.

Among 69 treatment-naive patients, the overall response rate was 84% (95% confidence interval [CI] = 73%–92%), with a duration of response of 20.2 months (95% CI = 13 months to not estimable). Among 247 patients previously treated with platinum-based chemotherapy, the overall response rate was 61% (95% CI = 55%–67%), with a duration of response of 28.6 months (95% CI = 20 months to not estimable). The most common adverse reactions (≥ 25%) in patients who received selpercatinib were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.

The recommended selpercatinib dose is based on body weight (< 50 kg: 120 mg orally twice daily; ≥ 50 kg: 160 mg orally twice daily). For more information on this indication for selpercatinib, see the full prescribing information.

U.S. Food and Drug Administration

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