European Commission Approves Ibrutinib in Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated CLL

The European Commission has granted Marketing Authorization for the expanded use of ibrutinib in an all-oral, fixed-duration treatment combination with venetoclax for adults with previously untreated chronic lymphocytic leukemia (CLL).

Ibrutinib is a once-daily oral medication that blocks the Bruton’s tyrosine kinase protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread. In Europe, ibrutinib is approved as a continuous therapy in several indications across three blood cancers (CLL, mantle cell lymphoma, and Waldenström’s macroglobulinemia).

The approval is based on the phase III GLOW study that demonstrated superior progression-free survival in patients treated with ibrutinib plus venetoclax versus chlorambucil plus obinutuzumab, and the fixed-duration cohort of the phase II CAPTIVATE study, which showed deep and durable responses, including in patients with high-risk features.

Source: Business Wire via the Janssen Pharmaceutical Companies of Johnson & Johnson, August 2022