Gilead Withdraws Trodelvy in Bladder Cancer Amid Trial Setbacks

Gilead Sciences has withdrawn Trodelvy for bladder cancer following a failed TROPiCS-04 trial, which showed no survival advantage over chemotherapy[1][2]. Originally granted accelerated approval in 2021, Trodelvy's efficacy in shrinking tumors was undermined by these results[2]. This decision follows FDA discussions and echoes a broader trend of withdrawing conditional approvals after negative trial outcomes, such as seen with other companies like GSK and Takeda[1]. Despite this setback, Trodelvy remains approved for breast cancer and is projected to maintain significant sales growth in that area[1][2].
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What impact will the withdrawal of Trodelvy for bladder cancer have on Gilead's financial performance?
How does Trodelvy's failure in the TROPiCS-04 trial influence future drug development strategies at Gilead?
What are the projected sales figures for Trodelvy in breast cancer by 2030?
How does the FDA's growing caution in maintaining accelerated drug approvals affect the biotech industry as a whole?
What potential does Trodelvy hold in ongoing trials for lung and triple-negative breast cancers?