AbbVie Plans to Submit Applications for New Drug for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
September 16, 2015
AbbVie Plans to Submit Applications for New Drug for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia with 17P Deletion. This phase 2 study meets it’s primary endpoint as it plans to submit Venetoclax regulatory applications to the FDA and EMA.
The open-label study evaluated the efficacy and safety of venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche.
Data from this study will be presented at an upcoming medical conference and will serve as the pivotal registration data for applications to the FDA, EMA and other health authorities. The safety profile was similar to previous studies and no unexpected safety signals were reported for venetoclax.
“The results from this study demonstrate the clinical activity of venetoclax in patients with relapsed/refractory CLL who have 17p deletion, a patient population that has historically been difficult to treat,” said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. “Based on these results, we intend to advance regulatory submissions for venetoclax and remain committed to the further development of this investigational medicine, and others in our pipeline, with the goal of delivering new treatment options for people affected by cancer.”
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