Selpercatinib Granted Full Approval by the FDA for Locally Advanced/Metastatic RET+ NSCLC

Patients with RET fusion–positive locally advanced/metastatic non–small cell lung cancer can now receive treatment with RET inhibitor selpercatinib, which was approved by the FDA.

The FDA has granted approval to selpercatinib as a treatment for patients with locally advanced or metastatic non–small cell lung cancer with a RET fusion detected via an FDA approved test, according to a press release from the regulatory organization.

The agent was granted accelerated approval by the FDA in May 2020 based on findings from the phase 1/2 LIBRETTO-001 trial (NCT03157128) which had a population of 144 patients at the time. The full approval was granted based on data from an additional 172 patients and 18 months of additional follow-up. In the population of 316 patients, the overall response rate by blinded independent central review was 84% (95% CI, 73%-92%) and the duration of response was 28.6 months (95% CI, 20-not estimable).

The recommended dosing for selpercatinib is 120 mg twice daily for those who weigh less than 50 kg and 160 mg twice daily for those who weigh 50 kg or more.

Common adverse effects included edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.


FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer. News release. FDA. September 21, 2022. Accessed September 22, 2022.