FDA grants regular approval to venetoclax for CLL/SLL


Venetoclax (Venclexta) has received regular approval from the Food and Drug Administration 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 one prior therapy.

The approval was based results from the MURANO trial of 389 patients, which was a randomized, multicenter, open-label trial of venetoclax plus rituximab versus bendamustine plus rituximab.

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Efficacy in this trial was based on progression-free survival. After a median follow-up of 23 months, the median progression-free survival had not been reached in the venetoclax arm, while it was 18.1 months in the bendamustine arm (hazard ratio, 0.19; 95% confidence interval, 0.13-0.28; P less than .0001). The venetoclax arm had an overall response rate of 92%, compared with 72% in the bendamustine arm.

Neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea were the most common adverse events seen in the venetoclax arm. Grade 3 or 4 neutropenia developed in 64% of those patients, and grade 4 in 31%. The most common infection in venetoclax patients was pneumonia, but overall, 21% of patients in that arm experienced some kind of infection.

Because of the rapid reduction in tumor size, tumor lysis syndrome is possible with venetoclax treatment, the FDA noted.

In 2016, the FDA granted accelerated approval to venetoclax for treatment of patients with CLL with 17d deletion who had received at least one prior line of therapy.

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