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Fixed-duration ibrutinib + venetoclax receives EC approval as first-line treatment for chronic lymphocytic leukemia
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On August 4, 2022, it was announced that the European Commission (EC) had granted approval to ibrutinib, a Bruton’s tyrosine kinase inhibitor, in combination with venetoclax, a BCL-2 inhibitor, as an oral fixed-duration regimen for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The approval is based on key data obtained from the phase III GLOW and phase II CAPTIVATE clinical trials (NCT03462719; NCT02910583).1
The GLOW trial reported a superior progression-free survival for ibrutinib + venetoclax over chlorambucil-obinutuzumab in elderly and unfit adult patients with CLL. The CAPTIVATE trial showed that treatment with ibrutinib + venetoclax led to deep and durable responses in patients ≤70 years of age with previously untreated CLL.
- Business Wire. European Commission approves Imbruvica® (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia (CLL). https://www.businesswire.com/news/home/20220801005417/en/European-Commission-Approves-IMBRUVICA%C2%AE-ibrutinib-in-a-Fixed-Duration-Combination-Regimen-for-Adult-Patients-with-Previously-Untreated-Chronic-Lymphocytic-Leukaemia-CLL. Published Aug 4, 2022. Accessed Aug 4, 2022.
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