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FDA approves Eli Lilly's Inluriyo with Verzenio
The gist
The FDA granted full approval to Eli Lilly's Inluriyo plus Verzenio for ESR1-mutated advanced breast cancer.
The combo gives Lilly a second-line option in a fast-moving oral SERD race.
How it unfolded
- Dec 2024Progression-free survival data from the phase 3 EMBER-3 trial were made public.
- Sep 2025The FDA approved Inluriyo (imlunestrant) as a monotherapy for metastatic, or Stage IV, breast cancer with ESR1 mutations.
- Sep 18, 2026The FDA granted full approval to Inluriyo combined with Verzenio (abemaciclib) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one prior line of endocrine therapy. The agency also approved the Guardant360 CDx assay as a companion diagnostic for the combination.