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# Lilly’s Inluriyo OK’d for Breast Cancer
- URL: https://www.fdaweb.com/lillys-inluriyo-okd-for-breast-cancer/
- Published: 2025-09-25T12:00:00.000Z
- Updated: 2026-09-14T15:22:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159939

FDA has approved an Eli Lilly NDA for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist for treating adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

Approval was based on data from the Phase 3 EMBER-3 trial that showed Inluriyo reduced the risk of progression or death by 38% versus ET, Lilly says. “Among patients with *ESR1*\-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months…,” it adds.

The drug’s label has a warning and precaution for embryo-fetal toxicity. “In EMBER-3, the majority of adverse events (AEs) with Inluriyo were low grade (Grade 1-2) and the most common adverse reactions (greater than 10%), including laboratory abnormalities, were hemoglobin decreased, musculoskeletal pain, calcium decreased, neutrophils decreased, AST increased, fatigue, diarrhea, ALT increased, triglycerides increased, nausea, platelets decreased, constipation, cholesterol increased, and abdominal pain,” Lilly says.

The company says Inluriyo is also being studied in the ongoing Phase 3 EMBER-4 trial in the adjuvant setting for people with ER+, HER2– early breast cancer who are at increased risk of recurrence.