Pembrolizumab (new indication: colorectal cancer with MSI-H or dMMR tumors for patients treated with fluoropyrimidine-based combination therapy)



  • Active Sustance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Colorectal 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:

  1. A patient-indivdual therapy depending on the type and number of prior therapies, RAS and BRAF mutation status, location of the primary tumor, general condition, and risk of toxicity induced by anti-VEGF and anti-VEGFR agents choosing from:
    - 5-fluorouracil + folinic acid + irinotecan (FOLFIRI) ± OR bevacizumab or aflibercept or ramucirumab OR
    - FOLFIRI ± cetuximab or panitumumab (only for patients wit RAS wild type) OR
    - combination therapy of 5-fluorouracil + folinic acid + oxaliplatin (FOLFOX) ± bevacizumab OR
    - capecitabine + oxaliplatin (CAPOX) ± bevacizumab OR
    - 5-fluorouracil + folinic acid ± bevacizumab OR
    - capecitabine ± bevacizumab OR
    - irinotecan (monotherapy) OR
    - panitumumab (monotherapy, only for patients with RAS wild type) OR
    - cetuximab (monotherapy, only for patients with RAS wild type) OR
    - trifluridine/tipiracil
    - irinotecan + cetuximab (only for patients with RAS wild type) OR
    - encorafenib + cetuximab (only for patients with BRAF-V600E mutation)