VENCLEXTA (venetoclax) tablets, for oral use. Initial U.S. Approval: 2016

VENCLEXTA (venetoclax) tablets, for oral use. Initial U.S. Approval: 2016

INDICATIONS AND USAGE
VENCLEXTA is a BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
DOSAGE FORMS & STRENGTHS
Tablets: 10 mg, 50 mg, 100 mg
Manufactured By: AbbVie Inc
Prescribing Information URL: Click Here

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In the US, venetoclax is indicated 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+).
In the EU, venetoclax monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adults who are unsuitable for or have failed a B cell receptor pathway inhibitor and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adults who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor.
Other types of leukemia
Venetoclax is also indicated 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 who are age 75 years or older, or those with other health problems where intensive chemotherapy cannot be used.

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