Gilead: Trodelvy Gets Accelerated Approval to Treat Some Metastatic Urothelial Cancer

   By Stephen Nakrosis

Gilead Sciences, Inc. on Tuesday said the Food and Drug Administration granted accelerated approval to Trodelvy to treat certain adult patients with metastatic urothelial cancer.

The accelerated approval for Trodelvy, or sacituzumab govitecan-hziy, is for the treatment of "adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor," Gilead said.

The new indication marks the second FDA approval for Trodelvy this year, according to Gilead.

The FDA said the Accelerated Approval Program allows "for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint."

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

April 13, 2021 18:39 ET (22:39 GMT)

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