The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).1
Breakthrough Therapy Designation by the FDA is intended to expedite the development and review of therapies for serious or life-threatening conditions.
This designation is based on a phase 1 study that is evaluating the safety and tolerability of the combination in up to 50 patients with relapsed/refractory CLL.
“This second Breakthrough Therapy Designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed/refractory CLL patients, and reflects AbbVie’s commitment to providing breakthrough therapies for cancer patients,” said Michael Severino, MD, executive vice president of research and development and chief scientific officer, AbbVie.
“AbbVie will continue harnessing our collective expertise to accelerate efforts to bring new treatment options to patients battling this difficult to treat blood cancer.”
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Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor being assessed for the treatment of numerous cancer types.
In April 2015, the FDA granted Breakthrough Therapy Designation to venetoclax monotherapy for the treatment of patients with previously treated CLL and a 17p deletion. The FDA has also granted priority review for the single agent venetoclax New Drug Application.
- Abbvie’s venetoclax receives breakthrough therapy designation from FDA in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia [news release]. North Chicago, IL: AbbVie; January 20, 2016. http://abbvie.mediaroom.com/2016-01-20-AbbVies-Venetoclax-Receives-Breakthrough-Therapy-Designation-from-FDA-in-Combination-with-Rituximab-for-the-Treatment-of-Patients-with-Relapsed-Refractory-Chronic-Lymphocytic-Leukemia. Accessed January 21, 2016.