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EC authorizes label expansion for venetoclax combinations in CLL
On May 29, 2026, the European Commission (EC) authorized a label expansion for venetoclax to include its use in combination with acalabrutinib ± obinutuzumab and in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL).1
Authorization of the label expansion to include venetoclax in combination with acalabrutinib ± obinutuzumab was supported by results from the phase III AMPLIFY (NCT03836261) trial, in which venetoclax + acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy in adult patients with previously untreated CLL without del(17p) or mutated TP53.1,2 The median progression-free survival (PFS) was not reached with acalabrutinib + venetoclax vs 47.6 months for chemoimmunotherapy.1,2 The most common adverse events (AEs) of any grade with venetoclax + acalabrutinib were headache (35%), diarrhea (33%), musculoskeletal pain (25%), COVID-19 (21%), fatigue (18%), bruising (17%), rash (16%), and nausea (15%).1,2
Authorization of the label expansion to include venetoclax in combination with ibrutinib was supported by results from the phase III GLOW (NCT03462719) and phase II CAPTIVATE (NCT02910583) trials. The GLOW trial evaluated venetoclax in combination with ibrutinib or chlorambucil + obinutuzumab in patients with previously untreated CLL.1,3 At 64 months follow-up, venetoclax + ibrutinib reduced the risk of disease progression or death by 73% compared with chlorambucil + obinutuzumab and resulted in a median PFS of 65 months vs 23 months.1,3 The safety profile of venetoclax + ibrutinib was consistent with the safety profile of venetoclax and ibrutinib alone.1,3 The CAPTIVATE trial evaluated minimal residual disease (MRD)-guided discontinuation and fixed-duration venetoclax + ibrutinib in patients with previously untreated CLL or small lymphocytic lymphoma (SLL).1 The combination demonstrated 5.5-year PFS and overall survival (OS) rates of 66% and 97%, respectively.1,4
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What is the primary reason you use bridging therapy in patients with DLBCL awaiting CAR T-cell therapy?
