AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets
The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion.
AbbVie has announced the FDA has granted accelerated approval of Venclexta (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is marketed collaboratively by the companies in the US and by AbbVie outside of the US.
"The FDA's approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed/refractory CLL who harbor the 17p deletion," said Richard Gonzalez, chairman of the board and chief executive officer of AbbVie. "BCL-2 inhibition is a novel mechanism which brings a new treatment option to patients who need additional therapies."
AbbVie expects Venclexta, a tablet taken orally, will become commercially available in the US within a week.
"Results from the clinical trial program show that Venclexta provides significant overall response among previously treated patients with CLL with 17p deletion," said Matthew S. Davids, a physician at the Dana-Farber Cancer Institute, Assistant Professor of Medicine at Harvard Medical School, and a leading principal clinical investigator in the Venclexta clinical trial program. "Based on the efficacy and safety profile observed in the clinical trials, Venclexta can be an important and unique addition in the fight against relapsed/refractory CLL in patients with 17p deletion."
"The approval of Venclexta as a first-in-class BCL-2 inhibitor gives physicians an important option for the treatment of relapsed/refractory CLL harboring the 17p deletion," said Michael Severino, executive vice president of research and development and chief scientific officer, AbbVie. "With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer."
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