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US FDA Fine-Tunes Tecentriq, Keytruda First-Line Bladder Cancer Accelerated Approval Indications

 
• By Emily Hayes and Bridget Silverman

FDA’s decision to restrict use based on the level of PD-L1 expression shows how confirmatory trials for accelerated approval can help to inform and adapt labeling. 

car racing in tunnel

A June 19 labeling change for two PD-1/L1 inhibitors in bladder cancer shows how FDA is matching the regulatory flexibility that has nurtured rapid growth in immuno-oncology approvals with strong (yet still flexible) surveillance oversight after marketing.

Labels for Roche's Tecentriq (atezolizumab) and Merck & Co. Inc.'s Keytruda (pembrolizumab) now limit the first-line indications for...

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More from Approvals

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Ekterly, KalVista Pharmaceuticals’ treatment for acute attacks of hereditary angioedema.

US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 
• By Bridget Silverman

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

More from Product Reviews

New EU Variations Guidelines: More Flexibility, New Obligations

 
• By Vibha Sharma

Drug companies are being urged to review their internal processes to ensure compliance with new requirements in the EU’s variations guidelines, which take effect in January 2026.

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.

Vaccine Safety: ACIP Members Want Long-Term Adverse Effect Studies

 
• By Sue Sutter

The risks, as well as the benefits, of vaccination could be long-term, Advisory Committee on Immunization Practices member Retsef Levi said. The FDA’s Tracy Beth Høeg also said long-term safety data are needed to inform the benefit-risk analysis of the hepatitis B birth dose.