FDA Approves Lilly Metastatic Breast Cancer Therapy

(Dreamstime)

Thursday, 25 September 2025 04:00 PM EDT ET

Eli Lilly said on Thursday that the U.S. Food and Drug Administration has approved its therapy for the treatment of metastatic breast cancer in patients whose disease progressed after at least one line of endocrine therapy.

The therapy, Inluriyo, was approved based on data from a late-stage trial in which patients had a 38% lower chance of their cancer progressing or death compared to those on standard treatments, the drugmaker said.

Metastatic breast cancer, also called Stage IV breast cancer, occurs when cancer has spread beyond the breast and nearby lymph nodes to other parts of the body, most commonly the bones, lungs, liver or brain.

Inluriyo is expected to be available in the United States in the coming weeks, the company said.

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Eli Lilly said on Thursday that the U.S. Food and Drug Administration has approved its therapy for the treatment of metastatic breast cancer in patients whose disease progressed after at least one line of endocrine therapy. The therapy, Inluriyo, was approved based on data...
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