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FDA Approves Venetoclax for CLL

Jason M. Broderick @jasoncology
Published: Monday, Apr 11, 2016

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has granted an accelerated approval to the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy. 

Simultaneous with the presentation of the phase II data at ASH, results of a phase I dose-escalation study of venetoclax among patients with CLL were published in The New England Journal of Medicine.2 In this study, the ORR was 79% with venetoclax among 116 patients treated during the study, including a CR in 20% of participants. The 15-month progression-free survival estimate for patients who received the highest dose of 400 mg per day was 69%.
All participants in that study had relapsed CLL and more than one-third were refractory to their last treatment, but the study was not restricted to patients with a 17p deletion.
Today’s regulatory approval follows an FDA breakthrough therapy designation granted to venetoclax in April 2015 for previously treated patients with del(17p) CLL.

“Up to half of people whose CLL progressed have 17p deletion, a genetic marker that makes the disease difficult-to-treat,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, which codevelops venetoclax along with AbbVie, said in statement. “Venclexta is the first approved medicine designed to trigger a natural process that helps cells self-destruct, and is a new way to help people who have been previously treated and have this high-risk form of the disease.”

Also commenting on the approval, Richard Gonzalez, chairman and CEO of AbbVie, said, “This FDA approval marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed/refractory CLL who harbor the 17p deletion. BCL-2 inhibition is a novel mechanism which brings a new treatment option to patients who need additional therapies.”

Under the accelerated program, full approval for venetoclax is contingent upon findings from a confirmatory study. At this time, there are currently two phase III trials assessing venetoclax in combination with anti-CD20 antibodies for patients with CLL.


  1. Stilgenbauer S, Eichhorst BF, Schetelig JS, et al. Venetoclax (ABT-199/GDC-0199) monotherapy induces deep remissions, including complete remission and undetectable MRD, in ultra-high risk relapsed/refractory chronic lymphocytic leukemia with 17p deletion: results of the pivotal international phase II study. Presented at: 57th American Society of Hematology Annual Meeting; Orlando, Florida; December 5-8, 2015. Abstract LBA6.
  2. Roberts AW, Davids MS, Pagel JM, et al. Targeting BCL2 with venetoclax in relapsed chronic lymphocytic leukemia. N Eng J Med. doi:10.1056/NEJMoa1513257. 2016;374(4):311-322. 


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