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AbbVie gets FDA breakthrough therapy status for venetoclax to treat CLL

AbbVie has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational medicine venetoclax to treat chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein, which AbbVie is currently developing in partnership with Genentech and Roche.

It is designed to selectively inhibit the function of the BCL-2 protein, which prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types.

Currently, the companies are committed to BCL-2 research with venetoclax, which is being evaluated in Phase II and Phase III clinical trials to treat CLL, along with studies in several other cancers.

AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: "The Breakthrough Therapy Designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion.

"The continuing advancement of the venetoclax development program is one example of AbbVie’s focus on delivering innovative medicines that address unmet clinical needs."

CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, and it accounts for about one quarter of the new cases of leukemia diagnosed in the US.