Gilead Gets FDA Expanded OK of Trodelvy in Pre-Treated HR+/HER2- Metastatic Breast Cancer

By Colin Kellaher

Gilead Sciences Inc. on Friday said the U.S. Food and Drug Administration approved the expanded use of its breast-cancer drug Trodelvy in patients with a difficult-to-treat form of the disease.

The Foster City, Calif., biopharmaceutical company said the approval covers Trodelvy for adults with unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative, or HR+/HER2-, breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Gilead said the FDA approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from a Phase 3 study of Trodelvy, the prized drug in Gilead's $21 billion acquisition of Immunomedics in 2020. Trodelvy sales rose 79% last year to $680 million.

HR+/HER2- breast cancer, the most common type of breast cancer, accounts for roughly 70% of all new cases, or nearly 400,000 diagnoses worldwide each year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 03, 2023 10:58 ET (15:58 GMT)

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