Zanubrutinib (new indication: chronic lymphocytic leukemia (CLL), for relapsed and/or refractory patients)



  • Active Substance: Zanubrutinib
  • Name: Brukinsa®
  • Therapeutic area: Chronic lymphocytic leukemia (CLL)
  • Pharmaceutical company: BeiGene Germany GmbH


Time table:

  • Start: 15.12.2022
  • Publication of assessment: 15.03.2023
  • End of public hearing: 05.04.2023
  • Final decision by G-BA: middle of June 2023


Comparative therapy:

  1. Patients who have not yet received a BTK inhibitor and/or BCL2 inhibitor:
    - Ibrutinib OR
    - venetoclax + rituximab OR
    - chemoimmunotherapy with FCR or BR or ClbR (in each case, only in the case of a long relapse-free interval and absence of genetic risk
  2. Patients after prior therapy with at least one BTK inhibitor:
    - Venetoclax + rituximab
  3. Patients after prior therapy with at least one BCL2 inhibitor:
    - Ibrutinib
  4. Patients after prior therapy with at least one BTK inhibitor and one BCL2 inhibitor: A patient-individual therapy depending on the success and tolerability of the previous therapy, the general condition, comorbidities and genetic risk factors, choosing from:
    - Idelalisib in combination with rituximab, bendamustine, in combination with rituximab, chlorambucil in combination with rituximab, and best supportive care.