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FDA Extends Full Approval For Merck's Keytruda In 1st-Line Bladder Cancer

Benzinga · 09/01/2021 07:23
  • The FDA gave its full approval to Merck & Co Inc's (NYSE:MRK) Keytruda as a treatment for first-line advanced urothelial carcinoma (bladder cancer) patients who are not eligible for platinum-based chemo.
  • Keytruda earned an accelerated nod in first-line locally advanced or metastatic urothelial cancer (UC) patients who were not eligible for chemo back in May 2017. 
  • But the confirmatory KEYNOTE-361 study, which aimed to expand Keytruda into patients who had been previously treated with platinum-based chemo, failed both of its key primary endpoints, effectively shutting down Keytruda's broader use.
  • Earlier this year, Keytruda's first-line approval in bladder cancer was one of the indications considered by an FDA adcomm for continued support. 
  • The adcomm voted 5-3 to maintain the accelerated approval.
  • Related Content: Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: MRK shares are up 0.73% at $76.85 during the premarket session on the last check Wednesday.