publication date: Jan. 22, 2016

Venetoclax Receives FDA Breakthrough Therapy Designation 


FDA granted a Breakthrough Therapy Designation to venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia.

Venetoclax is an inhibitor of the B-cell lymphoma-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.

In April 2015, 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. In January, AbbVie announced that the FDA granted priority review for the single agent NDA application.

“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, executive vice president of research and development and chief scientific officer at 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.”


FDA granted Priority Review to lenvatinib for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma in combination with everolimus following one prior vascular endothelial growth factor-targeted therapy. FDA previously granted lenvatinib Breakthrough Therapy designation for this investigational indication.

Continue reading 42-03 Venetoclax Receives FDA Breakthrough Therapy Designation
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