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Merck Reports the US FDA Acceptance of sBLA for Keytruda (pembrolizumab) to Treat Advanced or Unresectable Biliary Tract Cancer

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Merck Reports the US FDA Acceptance of sBLA for Keytruda (pembrolizumab) to Treat Advanced or Unresectable Biliary Tract Cancer

Shots:

  • The US FDA has accepted an sBLA seeking approval of Keytruda + CT for LA unresectable or metastatic BTC. The US FDA’s decision is expected in Feb 2024
  • The sBLA was based on the P-III trial (KEYNOTE-966) evaluating Keytruda (200mg, q3w for ~2yrs.) + CT vs PBO + CT in 1069 patients showed an improvement in OS, a 17% reduction in risk of death after a median follow-up of 25.6mos., m-OS (12.7 vs 10.9mos.), 1 & 2 yr. OS rate (52% & 24.9% vs 44% vs 18.1%), respectively
  • The safety profile was consistent with prior reported studies, grade 3-4 TRAEs (70% vs 69%); TRAEs led to death (2% vs 1%) with no new safety signals, grade 3-4 immune-mediated AEs (7% vs 4%); patient experienced immune-mediated AEs that resulted in death (1%)

Ref: Merck | Image: Merck

Related News:- Precigen Receives the US FDA’s IND Clearance of PRGN-2009 + Pembrolizumab for the Treatment of Recurrent or Metastatic Cervical Cancer

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Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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