Fixed-duration Imbruvica + Venclexta combination is approved in Canada for previously untreated CLL/SLL
Health Canada has approved the fixed-duration, all-oral combination of ibrutinib (Imbruvica) and venetoclax (Venclexta) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion
The regulatory decision was supported by data from the phase III GLOW trial (NCT03462719) and the fixed-duration cohort of the phase II CAPTIVATE trial (NCT02910583).
In the pivotal GLOW study, at a median follow-up of 27.7 months (range, 1.7-33.8), findings showed that the median progression-free survival (PFS) for patients treated with ibrutinib plus venetoclax was not reached (NR; 95% CI, 31.2-NR) vs 21.0 months (95% CI, 16.6-24.7) for those given chlorambucil plus obinutuzumab (Gazyva), per independent review committee (IRC) assessment (HR, 0.216; 95% CI, 0.131-0.357; P < .001). Data from CAPTIVATE demonstrated that ibrutinib plus venetoclax resulted in a 24-month PFS rate of 94% (95% CI, 88%-97%) in patients with CLL or small lymphocytic lymphoma (SLL) with high-risk features. Those without high-risk features experienced a 24-month PFS rate of 97% (95% CI, 89%-99%).
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