The U.S. Food and Drug Administration granted full approval to Eli Lilly’s Retevmo on Tuesday for treating advanced solid tumors. The approval applies to adult and pediatric patients aged two and older with locally advanced or metastatic tumors. Eligible patients must carry a specific genetic alteration known as a RET gene fusion.
This decision converts previous accelerated approvals for the tumor-agnostic indication into a traditional approval. Clinical benefit was confirmed by the LIBRETTO-001 trial, which showed a 47% overall response rate. The study included patients with various cancers, such as pancreatic and colorectal.
Retevmo provides a targeted therapy for patients who have progressed on prior treatments. It serves as a critical option for those with no other remaining treatment paths.