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Merck's Keytruda Survives 'Conflicted' Adcom Vote For Bladder Cancer Indication

 
• By Derrick Gingery

Many Oncologic Drugs Advisory Committee members struggled to decide whether the data showed a clinically meaningful benefit in the proposed bladder cancer indication.

FDA Advisory Committee Feature image
Those against a favorable benefit-risk assessment said the KEYNOTE-057 trial data was not adequate for Keytruda in the proposed high-risk bladder cancer indication.

Members of the Oncologic Drugs Advisory Committee were admittedly conflicted over the benefit-risk profile of Merck & Co. Inc.'s Keytruda in a high-risk bladder cancer, but still gave a positive recommendation on 17 December in part to help drug development in the disease.

Keytruda is proposed for treatment of adults with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma-in-situ (CIS) with or without papillary tumors, who are ineligible for or...

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