Gilead withdraws bladder cancer drug in US
Gilead withdraws bladder cancer drug in US after failed trial
Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for previously treated patients with a type of bladder cancer after consultation with the U.S. health regulator. The U.
Gilead pulls Trodelvy's approval in bladder cancer after trial flop, FDA discussions
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 NSCLC. Started in February 2023, the trial currently bears a primary completion date in January 2027.
Drugmaker Pulls Trodelvy's Bladder Cancer Approval
Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday. The decision was made in consultation with the FDA and does not affect the antibody-drug conjugate's other indications,
Gilead Withdraws ADC Trodelvy in Bladder Cancer After Trial Failure
The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.
Gilead withdraws Trodelvy in bladder cancer
The antibody drug conjugate didn’t help patients live longer in a confirmatory trial, prompting a review of its conditional approval in that indication.
FDA Accepts New Drug Application for UGN-102 in Bladder Cancer
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk non–muscle-invasive bladder cancer.
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