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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 for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion who have received at least 1 prior treatment; and for the combination treatment of newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years of age of over, or have other medical conditions that prevent the use of standard chemotherapy.

Development History and FDA Approval Process for Venclexta

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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