AbbVie and Roche's venetoclax gets second Breakthrough designation

20 January 2016
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The US Food and Drug Administration has 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 (NYSE: ABBV) in partnership with Swiss pharma giant Roche (ROG: SIX) and its subsidiary Genentech. Stock broker Cowen & Co has predicted that the drug, if approved, could capture annual sales of $2 billion by 2020.

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.

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