New York (May 15, 2019) – The U.S. Food and Drug Administration (FDA) announced it has approved the use of venetoclax (VENCLEXTA, AbbVie Inc. and Genentech, Inc.) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Venetoclax was previously approved by the FDA for the treatment of CLL/SLL patients whose front-line therapy has failed.
The approval is based on the Phase III CLL14 study, which showed venetoclax plus obinutuzumab (GAZYVA) reduced risk of disease progression or death by 67 percent compared to a standard of care in people with untreated CLL.
The FDA used the Real-Time Oncology Review and Assessment Aid Pilot Program for this application and granted priority review as well as orphan drug and breakthrough designations. A description of the FDA expedited programs can be found here.
“Each lymphoma patient’s experience is unique, and today’s approval offers patients with chronic lymphocytic leukemia a new treatment option and new opportunity for hope, ” said Meghan Gutierrez, Chief Executive Officer at the Lymphoma Research Foundation. “Chemotherapy-free agents and new methods of administration are important to ensuring that patients and their physicians, through shared decision making, are able to access the right treatments at the right time.”
For more information on this FDA approval visit the FDA’s website or lymphoma.org/CLLFDAUpdates.
Kinya P. Harte
Director of Communications and Marketing