AbbVie and Roche's venetoclax gets second Breakthrough designation
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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