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Keytruda's Proposed Bladder Cancer Indication: Is Delaying Cystectomy Really A Benefit?

 
• By Derrick Gingery

Oncologic Drugs Advisory Committee members wondered when Keytruda should be used since cystectomy can be curative and waiting could make the surgery more difficult.

Bladder as a normal and overactive urinary organ comparison representing the involuntary loss of urine concept as a healthy and unhealthy condition with 3D illustration elements.
Cystectomies in some patients with a high-risk bladder cancer could be tougher if delayed, advisory committee members argued. • Source: Shutterstock

Should Merck & Co. Inc.'s Keytruda be approved for a high-risk bladder cancer, practitioners may be forced to reconcile whether the possibility of delaying, rather than avoiding, a radical cystectomy would be a preferable option for patients.

Keytruda (pembrolizumab) is proposed for treatment of adults with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma-in-situ...

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More from US FDA Performance Tracker

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

More from Regulatory Trackers

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Global Pharma Guidance Tracker - May 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.