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

Subject:

• 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
   factors)
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.