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FDA Approves Drug for Chronic Lymphocytic Leukemia
The US Food and Drug Administration (FDA) has approved a drug for 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 drug, Venclexta (venetoclax, AbbVie Inc. and Genentech Inc.), was approved based on MURANO—a randomized (1:1), multicenter, open-label trial. Researchers compared Venclexta with rituximab (VEN+R) versus bendamustine with rituximab (B+R) in 389 patients with CLL who had received at least one prior line of therapy. Patients receiving VEN+R completed a 5-week ramp up of Venclexta followed by Venclexta 400 mg once daily for 24 months measured from the rituximab start date. Researchers initiated rituximab after the ramp-up period, and it was given for 6 cycles—375 mg/m2 intravenously on cycle 1 day 1 and 500 mg/m2intravenously on day 1 of cycles 2-6, with a 28-day cycle length. The researchers then compared the first study arm to patients who received 6 cycles of B+R—bendamustine 70 mg/m2 on days 1 and 2 of each 28-day cycle and rituximab.
Researchers determined the efficacy of the drug based on progression-free survival (PFS) as assessed by an Independent Review Committee. During the median follow-up of 23 months, the median PFS 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<0.0001).
Further findings demonstrated an overall response rate of 92% in the VEN+R arm compared to 72% for those treated with B+R.
The most common adverse reactions reported included, neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough, and nausea.—Julie Gould
