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FDA May be Getting Tougher, but Gives Trodelvy Nod for Triple-Negative Breast Cancer

April 9, 2021

Via: BioSpace

There has been discussion that the U.S. Food and Drug Administration (FDA) is getting tougher, and they are running an industry-wide evaluation of accelerated approvals. However, today the agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease. It was originally granted accelerated approval about a year ago.

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