Daratumumab (new indication: systemic light-chain amyloidosis, 1st line, in combination with cyclophosphamide, bortezomib and dexamethasone)


  • Active Substance: Daratumumab
  • Name: Darzalex®
  • Therapeutic area: Systemic light-chain amyloidosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.08.2021
  • Final decision by G-BA: 20.01.2022
  • This decision remains valid until: 01.03.2025

Final decision:

  • Patients for whom bortezomib in combination with cyclophosphamide and dexamethasone is the patient-individual therapy: Hint for a minor additional benefit
  • Patients for whom another therapy is the patient-individual therapy: No additional benefit proved