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Venclexta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved April 11, 2016)
Brand name: Venclexta
Generic name: venetoclax
Dosage form: Tablets
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • 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.

Development timeline for Venclexta

Apr 24, 2023Drug Combination Restores Ability of Leading Treatment to Signal for Death of Blood Cancer Cells
Oct 16, 2020Approval Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia
May 15, 2019Approval AbbVie Announces US FDA Approval of Venclexta (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients
Nov 21, 2018Approval Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy
Jun  8, 2018Approval Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
Apr 11, 2016Approval FDA Approves Venclexta (venetoclax) for Chronic Lymphocytic Leukemia with 17p Deletion
Jan 12, 2016FDA Grants Priority Review for Venetoclax New Drug Application
Dec  6, 2015Pivotal Phase II Study Showed Nearly 80 Percent of People with Hard-to-treat Type of Chronic Lymphocytic Leukemia Responded to Investigational Medicine Venetoclax

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.