AbbVie (ABBV) announced the U.S. Food and Drug Administration has approved, under priority review, VENCLEXTA in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. The approval is based on MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival for relapsed/refractory CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen. is being developed by AbbVie and Roche (RHHBY); it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
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