The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for venetoclax for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, according to a news release.1
Venetoclax, a small molecule inhibitor of the BCL-2 protein, is being developed as a partnership between Genentech and AbbVie. It was granted Breakthrough Therapy Designation by the FDA in April 2015 for similar treatment of people with previously treated relapsed or refractory CLL with 17p deletion.
The NDA is based on data from M13-982, a phase 2, open-label, single arm, multicenter study that evaluated the efficacy and safety of venetoclax, which included 107 patients with relapsed or refractory disease. Primary endpoint was overall response rate as determined by an independent review committee.
Results presented at the 57th American Society of Hematology (ASH) 2015 meeting showed that the study met its primary endpoint, with an overall response rate of 79.4% among all patients. Additionally. 7.5% of patients achieved a complete response with or without complete recovery of blood counts in the bone marrow.
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“Venetoclax is a potential new way to treat this difficult type of CLL,” said Sandra Horning, MD, chief medical officer of Genentech. “We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options.”
- FDA Grants Priority Review for Venetoclax New Drug Application [news release]. South San Francisco, CA. Genetech; January 12, 2016. http://www.gene.com/media/press-releases/14616/2016-01-12/fda-grants-priority-review-for-venetocla. Accessed January 29, 2016.