Posted by Michael Wonder on 09 Jun 2018
AbbVie announces U.S. FDA approval of Venclexta (venetoclax tablets) in combination with rituximab as a fixed duration treatment for chronic lymphocytic leukaemia or small lymphocytic lymphoma patients who have received one prior therapy
8 June 2018 - Patients receiving Venclexta plus rituximab achieved a high overall response rate of 92%.
AbbVie today announced the U.S. FDA has approved, under priority review, Venclexta (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukaemia (CLL) 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 (PFS) for relapsed/refractory (R/R) 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.
