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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.

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After a long wait for patients, Vykat has become the first drug approved for Prader-Willi syndrome symptoms, opening the market up for Soleno and future challengers.

Wave Aspires To Accelerated Approval In DMD With 48-Week Data

 
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Rybrevant/Lazcluze Survival Win Could Overcome Tagrisso’s Convenience Advantage

 
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