FDA grants priority review to new leukemia therapy
Venetoclax, a product in development by global biopharmaceutical company AbbVie, has been granted priority review for a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA). Venetoclax is indicated for patients who have tried at least one other therapy without success.
"The FDA acceptance of AbbVie's Venetoclax submissions marks a major step forward as we work to become a global leader in oncology, providing new therapies for patients with cancer," Dr. Michael Severino, chief scientific officer at AbbVie, said.
Venetoclax is being developed with assistance from scientists at Genentech and Roche.
The standard timeline for an NDA review is 10 months; therapies with priority review are assessed within six months.
CLL, the most commonly diagnosed form of leukemia in adults in western nations, is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.
Venetoclax works by blocking and killing B-cell lymphoma-2 (BCL-2). The drug was granted Breakthrough Therapy Designation this past April.
"Patients are always our number-one priority, and we accelerated our efforts to bring Venetoclax, the first BCL-2 inhibitor, to patients with CLL in need of new therapies, including those with 17p deletion who typically have a poor prognosis," Severino said.
A phase II study of Venetoclax concluded in August. The study showed a good overall response rate and zero unexpected safety events.