Additional Relevant Details
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.

In April 2015, the FDA granted Breakthrough Therapy Designation to single agent venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions. In January, AbbVie announced that the FDA granted priority review for the single agent NDA application.