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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

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.

The FDA granted accelerated approval of Venclexta based on efficacy data from an open-label, multicenter clinical trial of 106 previously-treated CLL patients with 17p deletion. Patients received daily Venclexta under a weekly ramp-up schedule and continued treatment until disease progression or unacceptable toxicity. Results showed an overall response rate (ORR) of 80 percent.

Venclexta is an oral tablet administered daily according to a dosing schedule, and swallowed whole with a meal and water.

The most common side effects reported during clinical trials include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infections, thrombocytopenia and fatigue.

Development History and FDA Approval Process for Venclexta

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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