02:38 PM EDT, 09/25/2025 (MT Newswires) -- Eli Lilly ( LLY ) said Thursday that the US Food and Drug Administration approved Inluriyo for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one prior endocrine therapy.

The approval is supported by results from the phase 3 Ember-3 trial, which showed that Inluriyo reduced the risk of disease progression or death by 38% compared with standard endocrine therapy, with a median progression-free survival of 5.5 months versus 3.8 months.

The once-daily oral drug inhibits and degrades estrogen receptors, offering a new treatment option for patients, the company said.

Eli Lilly ( LLY ) added that Inluriyo is expected to launch in the US in the coming weeks and is also being studied in the ongoing Ember-4 trial for patients with high-risk early breast cancer.

Shares of the company were down 3.8% in recent trading.

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