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Venetoclax FDA approved for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
By: News Feed | Last updated: 15th May 2019 | In: Haematology, US FDA Onc\Haem Approvals
AbbVie, chlorambucil, chronic lymphocytic leukaemia, Genentech, leukaemia, lymphoma, obinutuzumab, small lymphocytic lymphoma, Venclexta, venetoclax
The FDA approval was based on the multicentre, open-label, actively controlled CLL14 trial (NCT02242942) which randomised 432 previously untreated CLL patients with coexisting medical conditions 1:1 to receive venetoclax plus obinutuzumab vs obinutuzumab plus chlorambucil. The primary efficacy endpoint was the progression-free survival (PFS) as assessed by an independent review committee.
The CLL14 study showed a significant PFS improvement for patients treated with venetoclax plus obinutuzumab vs obinutuzumab plus chlorambucil (HR=0.33; 95% CI, 0.22-0.51; P<0.0001). After a median 28 months follow-up, the overall response rate measured 85% in the venetoclax plus obinutuzumab arm compared to 71% in the obinutuzumab plus chlorambucil arm (P=0.0007). Moreover, the study demonstrated a statistically significant improvement in the rate of minimal residual disease negativity (<1 CLL cell per 104 leukocytes) for bone marrow and peripheral blood. The median PFS and overall survival data were not yet mature.
Common adverse reactions in ≥20% of CLL/SLL patients treated with venetoclax plus obinutuzumab, rituximab, or as monotherapy included neutropenia, thrombocytopenia, anaemia, diarrhoea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and oedema.
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