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FDA Grants Full Approval to Gilead Breast Cancer Drug

The U.S. Food and Drug Administration late Wednesday issued full approval to Gilead Sciences’ breast cancer drug Trodelvy for certain groups of patients, expanding on the accelerated approval the drug received just over a year ago.

Trodelvy is now fully approved to treat patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two prior systemic therapies, at least one for metastatic disease . The April 2020 approval was slightly narrower, and was conditional on the completion of a Phase 3 trial.


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