The Food and Drug Administration (FDA) has approved Venclexta (venetoclax; AbbVie and Genentech) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion, who have received at least 1 prior therapy. 

The new approval was based results from the Phase 3 MURANO trial which included 389 patients with CLL who had received ≥1 prior line of therapy. Patients were randomized to either venetoclax with rituximab (VEN+R) or bendamustine with rituximab (B+R); efficacy was based on progression-free survival (PFS) as assessed by an Independent Review Committee. 

Results showed that after a median follow-up of 23 months, median progression free survival was not reached in the VEN+R arm and was 18.1 months (95% CI: 15.8, 22.3) in the B+R arm (HR 0.19; 95% CI: 0.13, 0.28; P<.0001). The overall response rate was 92% and 72% for the VEN+R and B+R arms, respectively.

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“This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment allowing patients the ability to stop treatment after approximately 2 years,” said Michael Severino, MD, executive vice president, research and development, and chief scientific officer, AbbVie.

The FDA has also expanded the Venclexta monotherapy indication to include CLL or SLL patients, with or without 17p deletion, who have received ≥1 prior therapy. Previously, this B-cell lymphoma-2 (BCL-2) inhibitor was approved under accelerated approval as monotherapy for the treatment of patients with CLL with 17p deletion who had received ≥1 prior therapy. 

Venclexta is supplied in 10mg, 50mg, and 100mg tablets.

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