Pembrolizumab (new indication: biliary cancer with MSI-H or dMMR tumors, pretreated patients)



  • Active Sustance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Biliary cancer
  • Pharmaceutical company: MSD Sharp & Dohme GmbH


Time table:

  • Start: 01.08.2022
  • Publication of assessment: 01.11.2022
  • End of public hearing: 22.11.2022
  • Final decision by G-BA: middle of January 2023


Comparative therapy:

  • Therapy at the physician's discretion, appropriate therapies include:
    • combination of folinic acid, 5-fluorouracil, and oxaliplatin (FOLFOX) OR
    • pemigatinib (only for patients with FGFR2 fusion or rearrangement) OR
    • encorafenib + binimetinib (for patients with BRFAF V600 mutation only) OR
    • Best Supportive Care