Lilly wins FDA expedited approval for Retevmo

On September 22, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has accelerated the approval of Retevmo (selpercatinib) for the expanded indication of patients with locally advanced or metastatic solid tumors carrying RET gene fusion positive. These patients had progressed during or after previous systemic therapy or did not have a satisfactory alternative treatment option. It is reported to be the world's first and only RET inhibitor for the treatment of solid tumors with RET gene fusion in an unlimited number of cancer types.

In addition, the FDA granted Retevmo full approval for the treatment of RET gene fusion in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). The FDA expanded the indication for Retevmo to include patients with locally advanced disease and converted its May 2020 accelerated approval for NSCLC to full approval. Selpercatinib is a highly potent selective RET inhibitor that blocks RET activity and helps prevent cancer cell growth, and has shown compelling preliminary evidence in patients with brain metastases. On May 8, 2020, it was approved by the FDA for the treatment of non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and thyroid cancer with RET gene fusion or mutation.

These approvals are based on data from the pivotal, multicenter, open-label, multi-cohort clinical trial LIBRETTO-001. In a cohort of patients with unlimited cancer types (n=41), Retevmo achieved an overall response rate of 44%, with a median response duration of 24.5 months, and 67% of patients with a response duration of more than 6 months.

Common adverse reactions include: Brain edema (49%), diarrhea (47%), fatigue (46%), dry mouth (43%), hypertension (41%), abdominal pain (34%), constipation (33%), rash (33%), nausea (31%), headache (28%), cough (24%), vomiting (22%), dyspnea (22%), bleeding (22%), joints Pain (21%) and prolonged QT interval (21%).