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Pembrolizumab (new indication: melanoma, patients aged ≥ 12 years, adjuvant therapy, monotherapy)

 

Subject:

  • Active Sustance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Melanoma
  • 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. Adults with stage IIB or IIC melanoma after complete resection; adjuvant treatment: Therapy at the physician's discretion with consideration of interferon alfa and watchful waiting
  2. Adolescents 12 years and older with stage IIB or IIC melanoma after complete resection; adjuvant treatment: Therapy at the physician's discretion with consideration of interferon alfa and watchful waiting
  3. Adolescents 12 years and older with stage III melanoma after complete resection; adjuvant treatment: Therapy at the physician's discretion (appropriate therapies include: dabrafenib in combination with tramentinib (only for patients with BRAF V600 mutation-positive melanoma in tumor stage III after complete resection) OR nivolumab)