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


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

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