> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AbbVie’s Venclexta Approved for Leukemia
- URL: https://www.fdaweb.com/abbvies-venclexta-approved-for-leukemia/
- Published: 2016-04-11T12:00:00.000Z
- Updated: 2026-09-14T20:53:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135318

> FDA has approved an AbbVie NDA for Venclexta (venetoclax) and its use in treating patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. An FDA [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm?ref=fdaweb.com) says the drug is the first agency-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL. A companion diagnostic, Roche’s Vysis CLL FISH probe kit, was also approved to help select appropriate patients for treatment.  
>  
> Approval was based on data from a single-arm clinical trial of 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. “Results showed that 80% of trial participants experienced a complete or partial remission of their cancer,” FDA says.