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Gilead Withdraws Trodelvy Bladder Cancer Claim

 
• By Mary Jo Laffler

The action, taken in consultation with the US FDA, follows the failure of the TROPiCS-04 study, which was the confirmatory trial for the urothelial cancer accelerated approval.

Bladder cancer medical concept as an anatomical organ symbol with microscopic malignant cells spreading in the human body as a health care 3D illustration.

Gilead is losing approximately 10% of the revenue stream for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) with the voluntary withdrawal of its urothelial cancer indication.

The TROP-2 targeting ADC brought in $1.06bn in 2023, and Gilead has said

Key Takeaways
  • Trodelvy received accelerated approval in 2021 for bladder cancer after prior treatment with chemo and a PD-1 inhibitor, with TROPiCS-04 as the confirmatory trial.
  • Gilead reported the failure of TROPiCS-04 in May

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