10:27 AM EDT, 10/18/2024 (MT Newswires) -- Gilead Sciences ( GILD ) said Friday it plans to withdraw the US accelerated approval for Trodelvy for the treatment of adults with locally advanced or metastatic urothelial cancer following consultation with the US Food and Drug Administration.

In 2021, Trodelvy was granted accelerated approval for metastatic urothelial cancer for patients who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 or programmed death-ligand 1 inhibitor.

A confirmatory TROPiCS-04 study for the indication did not meet the primary endpoint of overall survival in the intention-to-treat population, Gilead said. The withdrawal does not affect Trodelvy's other approved uses in the US or abroad, it added.

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