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FDA approves Gilead’s Trodelvy for expanded use in breast cancer

February 3, 2023


Gilead’s acquisition of Immunomedics was the centerpiece of executives’ plans to make the biotechnology company, long known for its HIV and hepatitis C drugs, a competitor in oncology. So far, however, analysts have been skeptical of how that plan has unfolded, as Gilead has hit some setbacks and Trodelvy has been outshone by AstraZeneca and Daiichi’s Enhertu.

Friday’s approval is a step forward, significantly widening the market for Trodelvy. The FDA’s clearance is specifically for patients with HR-positive, HER2-negative breast cancer that’s either metastasized or can’t be removed through surgery. Eligible patients must have previously received a hormone therapy and at least two other systemic treatments in the metastatic setting.

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