Gilead’s breast cancer drug secures U.S. FDA approval for expanded use

Feb 3 (Reuters) – Gilead Sciences Inc. (GILD.O) said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common type of breast cancer, marking the third approval for the drug.

It was approved in patients with an advanced form of breast cancer with subtype known as HR-positive/HER2-negative, who had stopped responding to at least two earlier courses of chemotherapies.

The drug will likely face competition from AstraZeneca (AZN.L)-Daiichi Sankyo’s (4568.T) Enhertu, which is approved to treat breast cancer patients with HER2-low type, a subset of HER2-negative breast cancer.

Trodelvy is already approved in the United States for metastatic triple-negative breast cancer and bladder cancer. It carries a payload that kills tumor cells, and targets a cell surface antigen known as Trop-2 on cancer cells.

The therapy, which Gilead acquired as part of its $21 billion buyout of Immunomedics in 2020, belongs to a class of drugs known as antibody-drug conjugate.

Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Shinjini Ganguli

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