Eli Lilly Wins Full FDA Approval for Selpercatinib in Solid Tumors

Eli Lilly and Company (NYSE: LLY) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted traditional approval for selpercatinib (brand name Retevmo) for the treatment of adult patients with advanced or metastatic solid tumors harboring RET gene mutations. The drug initially received accelerated approval in 2020 based on Phase 2 data; the new approval follows confirmation of efficacy in the Phase 3 LIBRETTO-431 trial.

The Product

Selpercatinib is an oral, selective RET kinase inhibitor. It targets tumors driven by RET mutations, including certain non-small cell lung cancers (NSCLC), medullary thyroid cancer, and other solid tumors. RET mutations occur in about 1-2% of lung cancer cases.

Pricing and Availability

Eli Lilly has not disclosed any price change following the new approval. The list price was approximately $20,000 per month before discounts and insurance. The drug is currently available in major markets.

Competition

Selpercatinib competes with pralsetinib (Gavreto) from Roche, which also received accelerated approval for similar indications. The traditional approval may give selpercatinib a regulatory edge.

Potential Impact on the Company

The full approval is expected to boost selpercatinib sales, which were around $500 million in 2025. It also strengthens Eli Lilly's oncology portfolio in precision medicine.