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FDA Updates Venetoclax CLL Label With MRD Data

Jason M. Broderick @jasoncology
Published: Tuesday, Sep 11, 2018

John F. Seymour, MBBS, PhD

John F. Seymour, MBBS, PhD
The FDA has added minimal residual disease (MRD) data from the phase III MURANO trial to the label for venetoclax (Venclexta) for its approved use in combination with rituximab (Rituxan) for previously-treated patients with chronic lymphocytic leukemia (CLL).

The FDA action was based on the overall data from MURANO, in which the median progression-free survival (PFS) at 23 months' median follow-up was not reached with venetoclax plus rituximab compared with 18.1 months (95% CI, 15.8-22.3) with BR (HR, 0.19; 95% CI, 0.13-0.28; P <.0001).2 The overall response rate was 92% versus 72%, respectively.
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