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AbbVie (ABBV) Announces Receipt of Accelerated FDA Approval for Venclexta in CLL
April 11, 2016 4:32 PM EDTAbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.1 The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine1 that selectively inhibits the BCL-2 protein.1 The BCL-2 protein... More
