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FDA grants priority review to venetoclax for CLL
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The FDA granted priority review to venetoclax for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy, including those with 17p deletion, according to a press release from the drug’s manufacturer.
Venetoclax (Genentech and AbbVie) — a small molecular inhibitor of the BCL-2 protein —previously received breakthrough therapy designation for the treatment of patients with relapsed or refractory CLL with 17p deletion.
Data from the phase 2 M13-982 study — presented at the 2015 ASH Annual Meeting and Exposition — demonstrated venetoclax met its primary endpoint, with an overall response rate of 79.4% among 107 patients with relapsed or refractory CLL. Further, 7.5% of patients achieved a complete response with or without complete recovery of blood counts in the bone marrow.
Of 45 patients with minimal residual disease (MRD) testing in the blood, 18 achieved MRD negativity.
At 1 year, 84.4% of all responses and 94.4% of MRD-negative responses had been maintained.
Seventy-two percent of patients achieved 1-year PFS, and 86.7% achieved 1-year OS.
Fever (7%), low red blood cell count as a result of immune response (7%), pneumonia (6%) and low white blood cell count with fever (5%) were the most common serious adverse events associated with venetoclax.
The most common grade 3 to grade 4 adverse events included low white blood cell count (40%), low red blood cell count (18%) and low platelet count (15%). Grade 3 or worse infection occurred in 20% of patients.
“Venetoclax is a potential new way to treat this difficult type of [CLL],” Sandra Horning, MD, chief medical officer at Genentech, said in the release. “We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options."