FDA Approves Oral Drug for ESR1‑Mutated Breast Cancer
The U.S. Food and Drug Administration approved Eli Lilly’s Inluriyo, an oral estrogen‑receptor antagonist, on Sept. 25, 2025 for adults with ER+, HER2‑, ESR1‑mutated advanced or metastatic breast cancer after disease progression on prior endocrine therapy. The approval is based on phase 3 EMBER‑3 results showing a 38% reduction in risk of progression or death and a median progression‑free survival of 5.5 months versus 3.8 months for comparator hormone treatments; the label includes safety warnings (lab abnormalities, GI and musculoskeletal symptoms) and a pregnancy risk warning.
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Pharmaceuticals
🔍 Key Facts
- FDA approved Inluriyo (Eli Lilly) Sept. 25, 2025 for adults with ER+, HER2‑, ESR1‑mutated advanced/metastatic breast cancer after prior endocrine therapy.
- Phase 3 EMBER‑3 trial: 38% reduction in risk of progression or death; median PFS 5.5 months with Inluriyo vs. 3.8 months with comparator endocrine therapy.
- Safety and use: common low‑grade adverse events included lab abnormalities, musculoskeletal pain, fatigue, GI symptoms; 4.6% discontinued for adverse events; drug carries a warning for pregnancy risk.