Treats estrogen receptor (ER)-positive, human epidermal growth … metastatic breast cancer. NDA 218881, held by Eli Lilly And Co. Imlunestrant Tosylate.
As of Nov 14, 2026, NDA 218881 (Inluriyo), held by Eli Lilly And Co, was first approved by FDA on Sep 25, 2025, with 1 approved supplement and 0 published complete response letters.
INLURIYO is indicated: as monotherapy, for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1 )-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. in combination with abemaciclib for the treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
| Sep 18, 2026 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| InluriyoEQ 200MG BASE · tablet;oral | Imlunestrant Tosylate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
