AbbVie Receives Breakthrough Therapy Designation for Venetoclax and Rituximab

January 21, 2016
BioPharm International Editors

FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.

On Jan. 20, 2016, AbbVie announced that FDA granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

CLL 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. According to a report from the American Cancer Society, CLL is the most common type of leukemia in the Western world. In the United States specifically, it is estimated that more than 14,000 people will be diagnosed with CLL this year.

The designation is supported by an investigational study of venetoclax in combination with rituximab in patients with R/R CLL. Rituximab is indicated in combination with fludarabine and cyclophosphamide for the treatment of patients with previously untreated and previously treated CD20-positive CLL.  Rituximab in combination with the investigational agent venetoclax is not approved for the treatment of R/R CLL.

Source: AbbVie