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Ibrutinib (new indication: chronic lymphocytic leukemia (CLL); first line; in combination with venetoclax)

Subject:

  • Active Substance: Ibrutinib
  • Name: Imbruvica®
  • Therapeutic area: Chronic lymphocytic leukemia (CLL)
  • Pharmaceutical company: Janssen-Cilag GmbH

 

Time table:

  • Start: 01.02.2023
  • Publication of assessment: 02.05.2023
  • End of public hearing: 23.05.2023
  • Final decision by G-BA: middle of July 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 therapy with FCR based on their general condition and comorbidities) OR
  • bendamustine in combination with rituximab (only for patients without genetic risk factors and who are not suitable for therapy with FCR according to the above criteria) OR
  • chlorambucil in combination with rituximab or obinutuzumab (only for patients without genetic risk factors and who are not eligible for FCR according to the above criteria).