FDA Grants Accelerated Approval for Cancer Drug by AbbVie and Roche

The US Food and Drug Administration has granted AbbVie’s and Roche’s Venclexta (venetoclax) accelerated approval for patients with a hard-to-treat type of chronic lymphocytic leukemia. Specially, the accelerated approval applies to people with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialized by AbbVie outside of the United States.

Venclexta was granted breakthrough therapy designation by the FDA for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion. Breakthrough therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The new drug application for Venclexta was granted priority review, a designation for medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease. A marketing authorization application (MAA) has also been validated by the European Medicines Agency (EMA).

Venclexta is a oral, once-daily small-molecule medicine that is designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in chronic lymphocytic leukemia (CLL) has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct.

AbbVie expects Venclexta will become commercially available in the U.S. within a week.

Source: Roche and AbbVie

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