Venetoclax Designated Breakthrough Therapy for CLL

AbbVie announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

Venetoclax is an investigational inhibitor of the B-cell lymphoma-2 (BCL-2) protein, which prevents apoptosis of some cells, including lymphocytes.

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Currently venetoclax is being evaluated in Phase 2 and Phase 3 clinical trials for the treatment of CLL, along with studies in several other cancers such as small lymphocytic lymphoma (SLL), non-Hodgkin's lymphoma, multiple myeloma and acute myelogenous leukemia (AML).

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