Eli Lilly and Company today announced that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for Retsevmo® (selpercatinib) as first-line monotherapy indicated for the treatment of adults with advanced rearranged during transfection ( RET) fusion-positive non-small cell lung cancer (NSCLC), not previously treated with a RET inhibitor. Retsevmo is a selective and potent RET kinase inhibitor with central nervous system activity that has previously been approved for treatment of adult patients with metastatic RET fusion-positive NSCLC who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

This approval is based on the Phase 1/2 LIBRETTO-001 trial, which is the largest clinical trial of patients with RET-driven cancers treated with a RET inhibitor. Results shared at the European Lung Cancer 2022 demonstrated:

Safety among patients in this cohort was consistent with the known safety profile of Retsevmo. In the safety population (all NSCLC patients that received at least one dose of Retsevmo, N=356), the most common adverse events (AEs in ≥25% of patients) were dry mouth, diarrhea, hypertension, increased ALT/AST, peripheral edema, constipation, rash, headache, and fatigue. Thirty-four patients discontinued due to an adverse event (10%), eleven (3%) of which were deemed related to Retsevmo.

A global, randomized, Phase 3 trial is currently recruiting and will compare treatment with Retsevmo to the current standard of care in the first-line treatment of advanced or metastatic RET fusion-positive NSCLC. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.