John F. Seymour, MBBS, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is supporting the approval of venetoclax (Venclexta) in combination with rituximab (Rituxan) for patients with chronic lymphocytic leukemia (CLL) who have received at least 1 previous therapy. AbbVie, who is a co-developer of venetoclax with Roche, announced the CHMP’s decision in a news release.
The CHMP’s positive opinion, as well as the FDA approval, are based on data from the phase III MURANO trial. Findings showed that, at a median follow-up of 23 months, the median progression-free survival (PFS) was not reached with venetoclax/rituximab compared with 18.1 months (95% CI, 15.8-22.3) in the bendamustine-plus-rituximab arm (BR; HR, 0.19; 95% CI, 0.13-0.28; P <.0001).1 The overall response rate favored the venetoclax arm, 92% versus 72%.
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