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Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday.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.
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.
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.
ENDPOINTS NEWS1d
Gilead pulls Trodelvy's ac­cel­er­at­ed la­bel in blad­der can­cer af­ter drug failed con­fir­ma­to­ry study
Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after ...
Gilead Voluntarily Withdraws Urothelial Cancer Drug in US
(Reuters) - Gilead Sciences said on Friday it was voluntarily withdrawing the U.S. approval for Trodelvy in previously ...
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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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What’s Trodelvy’s Success Rate?
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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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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Gilead to Present New Trodelvy® Data at the IASLC 2024 World Conference on Lung Cancer
7-10, 2024 in San Diego, Calif. Data to be highlighted across three oral presentations include: initial results from two cohorts of the EVOKE-02 study of Trodelvy ® (sacituzumab govitecan-hziy ...