Gilead Sciences said on Friday it was voluntarily withdrawing the U.S. approval for Trodelvy in previously treated patients ...
The antibody drug conjugate didn’t help patients live longer in a confirmatory trial, prompting a review of its conditional ...
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for ...
Trodelvy’s next big readout is EVOKE-03, which is testing the Gilead drug with Merck’s PD-1 inhibitor Keytruda in PD-L1-high ...
On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) announced plans to voluntarily withdraw the U.S. accelerated approval for ...
Medpage Today on MSN11h
Drugmaker Pulls Trodelvy's Bladder Cancer ApprovalSacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences ...
Gilead in 2021 won the FDA accelerated nod for Trodelvy in metastatic urothelial cancer, but continued approval was contingent on the outcome of a confirmatory study. The company in late May said that ...
Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after ...
have been withdrawn in bladder cancer as a result. Gilead said Trodelvy’s safety profile in the TROPHY study is consistent with previous observations in metastatic UC and other tumour types.
In the study, Trodelvy (sacituzumab govitecan ... its currently-approved indication of triple-negative breast cancer (TNBC) and bladder cancer, and justify the $21 billion the company paid ...
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