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Pembrolizumab (new indication: breast cancer, triple negative, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with chemotherapy)

 

Subject:

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

 

Time table:

  • Start: 01.07.2022
  • Final decision by G-BA: 15.12.2022
  • The decision remains valid until: 01.10.2024

 

Final decision:

  1. Pembrolizumab in combination with paclitaxel and carboplatin followed by pembrolizumab in combination with doxorubicin or epirubicin and cyclophosphamide (neoadjuvant) and pembrolizumab (adjuvant) compared to paclitaxel and carboplatin followed by doxorubicin or epirubicin and cyclophosphamide (neoadjuvant) and watchful waiting (adjuvant): Hint for a minor additional benefit

  2. Pembrolizumab in combination with a chemotherapy other than paclitaxel and carboplatin followed by pembrolizumab in combination with a chemotherapy other than doxorubicin or epirubicin and cyclophosphamide (neoadjuvant) and pembrolizumab (adjuvant) compared to a chemotherapy based on the physician’s discretion for neoadjuvant treatment followed by watchful waiting after surgery: No additional benefit proved