FDA Expands Venetoclax’s Approval to All Patients With CLL and SLL

The U.S. Food and Drug Administration (FDA) granted approval to venetoclax for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without del17p, who received at least one prior therapy.

The agency’s decision was based on data from a randomized trial comparing venetoclax with bendamustine, in combination with rituximab, in 389 patients. In the venetoclax group, the response rate was 92 percent, compared with 72 percent for those treated with bendamustine. At a median follow-up of 23 months (range not reported), progression-free survival was not reached in the venetoclax group, compared with 18.1 months in the bendamustine group (hazard ratio = 0.19; 95% CI 0.13-0.28; p<0.0001).

In patients receiving the venetoclax combination, the most common adverse events (AEs) included neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea. Serious AEs occurred in 46 percent of patients, and 21 percent of patients developed serious infections. The investigators also noted that rapid reduction in tumor volume makes tumor lysis syndrome an important risk to consider.

Source: FDA press release, June 8, 2018.