SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of Swiss drug maker Roche Holding AG (RHHBY), said that the U.S. Food and Drug Administration has accepted the New Drug Application and granted priority review for venetoclax for the treatment of people with chronic lymphocytic leukemia or CLL, who have received at least one prior therapy, including those with 17p deletion.
Venetoclax, an investigational medicine, is a small molecule inhibitor of the BCL-2 protein being developed in partnership with AbbVie. It was granted Breakthrough Therapy Designation by the FDA in April 2015 for the treatment of people with previously treated CLL with 17p deletion. The drug is a potential new way of treating the most common adult leukemia.
CLL is one of the most common forms of blood cancer, and each year there are an estimated 5,000 deaths from CLL in the United States.
The FDA grants priority review to medicines that it has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The NDA for venetoclax is based in part on data from the pivotal Phase II M13-982 study, an open-label, single arm, multicenter study evaluating the efficacy and safety of venetoclax in patients with relapsed, refractory or previously untreated CLL with 17p deletion.
Genentech noted that a Marketing Authorization Application has also been validated by the European Medicines Agency or EMA.
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