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Venetoclax/Rituximab Combo Approved in Europe for CLL

Jason M. Broderick @jasoncology
Published: Thursday, Nov 01, 2018

John F. Seymour, MBBS, PhD

John F. Seymour, MBBS, PhD
The European Commission has approved venetoclax (Venclyxto, EU; Venetoclax, US) for use in combination with rituximab (Rituxan) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) following at least 1 prior therapy.

The PFS benefit extended across patients subgroups, including high- and low-risk groups. The 2-year PFS rate among patients with chromosome 17p deletion was 81.5% in the venetoclax arm versus 27.8% with BR (HR, 0.13; 95% CI, 0.05-0.29). For patients without chromosome 17p deletion, the 2-year PFS rate was 85.9% versus 41.0% in favor of the venetoclax arm (HR, 0.19; 95% CI, 0.12-0.32).

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