AbbVie has gained approval from the FDA via priority review for Venclexta in combination with rituximab for the treatment of with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) 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.
Clinical trial patients who received Venclexta plus rituximab also achieved an overall response rate (ORR) of 92% and those who received the chemoimmunotherapy regimen achieved an ORR of 72%.
The safety profile of the combination is consistent with the known safety profile of Venclexta. The most common adverse reactions, greater than or equal to 20%, with Venclexta in combination with rituximab were neutropenia, diarrhoea, upper respiratory tract infection, fatigue, cough and nausea.
Venclexta plus rituximab is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration.
Venclexta has been granted four Breakthrough Therapy Designations from the FDA including for the combination treatment regimen of Venclexta plus rituximab for patients with R/R CLL.
The approval of the Venclexta plus rituximab treatment regimen marks the second approval granted under priority review by the FDA for Venclexta. Outside of the US, regulatory submissions to and reviews with health authorities are underway.