AbbVie announced that the U.S. Food and Drug Administration 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. 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.