Gilead to withdraw Trodelvy indication in USA
Biotech firm Gilead Sciences (Nasdaq: GILD) has announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
The decision was made in consultation with the US Food and Drug Administration (FDA) and does not impact the other approved Trodelvy indications in the USA or elsewhere.
Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the global Phase II, single-arm TROPHY-U-01 study.
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