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Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday.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 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.
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.
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 bladder cancer drug in US after failed trial
Gilead Sciences said on Friday it was voluntarily withdrawing the U.S. approval for Trodelvy in previously treated patients with a type of urothelial cancer after consultation with the regulator.
After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer treatment
Gilead Sciences is set to withdraw Trodelvy's accelerated approval for metastatic urothelial cancer following unsatisfactory results from the TROPiCS-04 study. However, the decision does not impact Trodelvy's other approved uses.
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Trodelvy May Improve Responses in Bladder Cancer Subtype
Trodelvy in locally advanced or metastatic urothelial cancer may provide another option for those whose disease progressed after checkpoint inhibitors. Trodelvy (sacituzumab govitecan) ...
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Trodelvy side effects: What you should know
Trodelvy (sacituzumab govitecan-hziy) is a brand-name IV infusion prescribed for certain cancers in adults. As with other drugs, Trodelvy can cause side effects, such as diarrhea, hair loss ...
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Trodelvy (sacituzumab govitecan-hziy) is a prescription drug used to treat certain breast and bladder cancers. Scientists have studied the success rate of Trodelvy and found it to be effective in ...
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