VENCLEXTA is a BCL-2 inhibitor indicated: • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. ( • In combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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Venetoclax, sold under the trade name Venclexta and Venclyxto, is a medication used to treat chronic lymphocytic leukemia (CLL). Venetoclax is used for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Indication does not depend on mutation status (e. g. 17p deletion, IGHV mutation, 12+). Venetoclax is also used as part of a combination therapy for acute myeloid leukemia (AML). For this purpose it is with azacitidine, decitabine, or low-dose cytarabine for newly-diagnosed adults over 75, or those with other health problems where intensive chemotherapy cannot be used.
VENCLEXTA® (venetoclax tablets) for oral use. Initial U.S. Approval: 2016
Generic Name: venetoclax
Tablets: 10 mg, 50 mg, 100 mg.
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