Gilead Gets Positive Opinion From European Regulators on Breast-Cancer Treatment

By Nicholas G. Miller


Gilead Sciences received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending the marketing authorization of its Trodelvy drug to treat breast cancer.

The recommendation focused on the drug as a first-line monotherapy for metastatic triple-negative breast cancer, a type of breast cancer associated with low survival rates, the biotechnology company said.

The European Commission decision on the additional Trodelvy indication is expected later this year, Gilead said.

Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of Trodelvy in this indication, it said.


Write to Nicholas G. Miller at nicholas.miller@wsj.com.


(END) Dow Jones Newswires

May 22, 2026 08:28 ET (12:28 GMT)

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