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 firstname.lastname@example.org
(END) Dow Jones Newswires
April 13, 2021 18:39 ET (22:39 GMT)
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