Venclexta Labeling Updated With Minimal Residual Disease Negativity Data

MRD-negativity is defined as

The Food and Drug Administration (FDA) has updated the labeling for Venclexta (venetoclax; AbbVie and Genentech) in combination with rituximab to include data about patients with previously-treated chronic lymphocytic leukemia (CLL) who achieved minimal residual disease (MRD)-negativity in the Phase 3 MURANO trial.

MRD-negativity is defined as <1 CLL cell per 10,000 lymphocytes detected in the blood or bone marrow using sensitive analytical models. The multicenter, open-label, randomized MURANO study (N=389) evaluated the safety and efficacy of Venclexta + rituximab vs bendamustine + rituximab (standard chemoimmunotherapy) in patients with relapsed or refractory CLL who received ≥1 prior therapy. Efficacy was based on progression-free survival (PFS); median PFS was not reached in the Venclexta arm vs 18.1 months in the bendamustine arm hazard ratio [HR] 0.19, 95% CI, 0.13, 0.28; P <.0001). 

MRD-negativity rate was then evaluated in patients who responded to treatment. Of the Venclexta-treated patients, 53% achieved MRD-negativity after 9 months of therapy vs 12% of patients treated with bendamustine. Among patients with a complete response or complete response with incomplete marrow recovery (CR/CRi), the MRD-negativity rate was 3% in the Venclexta arm vs 2% in the bendamustine arm at 9 months. 

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“Venclexta plus rituximab is the first chemotherapy-free combination for previously-treated CLL that allows patients the ability to stop treatment after approximately 2 years. This label expansion is another important milestone in our efforts to advance care for patients with difficult-to-treat blood cancers,” stated Michael Severino, MD, executive vice president, research and development, and chief scientific officer, AbbVie.

Venclexta, a first-in-class BCL2 inhibitor, is currently approved in combination with rituximab for the treatment of patients with CLL or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received ≥1 prior therapy. It is available as 10mg, 50mg, and 100mg strength tablets. 

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