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

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.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

More from Product Reviews