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Zanubrutinib (news indication: chronic lymphocytic leukemia (CLL), first line treatment)

 

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:

  • Ibrutinib OR
  • Ibrutinib in combination with rituximab or obinutuzumab OR
  • Fludarabine in combination with cyclophosphamide and rituximab [FCR] (only for patients without the presence of genetic risk factors and < 65 years of age who are suitable for a therapy with FCR based on their general condition and comorbidities) OR
  • Bendamustine in combination with rituximab or obinutuzumab (only for patients without genetic risk factors and who are not suitable for a therapy with FCR according to the above criteria).