Keytruda's Proposed Bladder Cancer Indication: Is Delaying Cystectomy Really A Benefit?
Oncologic Drugs Advisory Committee members wondered when Keytruda should be used since cystectomy can be curative and waiting could make the surgery more difficult.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Unanimous approval recommendation driven by data on durable responses and disease stability, although some advisory committee members suggest limiting indication to second-line use; FDA comments suggest concerns about design and feasibility of planned confirmatory trial.
Many Oncologic Drugs Advisory Committee members struggled to decide whether the data showed a clinically meaningful benefit in the proposed bladder cancer indication.