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# AbbVie’s Venclexta Approved for Combo Use
- URL: https://www.fdaweb.com/abbvies-venclexta-approved-for-combo-use/
- Published: 2018-06-08T12:00:00.000Z
- Updated: 2026-09-15T00:11:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141641

FDA has approved an AbbVie’s Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. 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% when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen,” the company says. Those taking Venclexta plus rituximab also achieved a 92% overall response rate. The most common adverse reactions in studies were neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough and nausea.