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Venclexta Approval History

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 History and FDA Approval Process for Venclexta

DateArticle
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
Aug 12, 2015Pivotal Phase II Study of Investigational Medicine Venetoclax Met Primary Endpoint in a Hard-To-Treat Type of Chronic Lymphocytic Leukemia
May  6, 2015Investigational Medicine Venetoclax Receives Breakthrough Therapy Designation
Dec  7, 2014Abbvie Presents Results From Phase 2 Study Of Investigational Compound Venetoclax (ABT-199/GDC-0199) In Acute Myelogenous Leukemia

Further information

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