FDA Drug Approval:VENCLEXTA – Drug and Device Digest

FDA BRIEF: Week of April 11, 2016

FDA approved

VENCLEXTA™ (venetoclax) tablets

Vysis CLL FISH probe kit

AbbVie Inc., North Chicago, Illinois, USA

Genentech, South San Francisco, California, USA  

Abbott Molecular, Des Plaines, Illinois, USA

INDICATION: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy ( approval based on overall response rate; continued approval contingent upon verification in confirmatory trial)


  •  15,000 new CLL cases diagnosed each year
  • 17p deletion lchromosomal abnormality ~ 10%
  • Need for new targeted therapy

REG PATHWAY:  Breakthrough Therapy Designation, Priority Review, Accelerated Approival, Orphan Drug

MECHANISM OF ACTION: Inhibitor of BCL-2, an antiapoptotic protein


  • Open-label, single-arm, multicenter trial (n=106); patients with CLL with 17p deletion who had received at least one prior therapy
  • 17p deletion was confirmed using Vysis CLL FISH Probe Kit
  • Primary Endpoint: Overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukemia guidelines : 80.2%
  • Median time to first response: 0.8 months
  • Median duration of response:  2.9 to 19.0+ months


  • Serious complications: Pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and metabolic abnormalities known as tumor lysis syndrome
  • Most common side effects: Low white blood cell count (neutropenia), diarrhea, nausea, anemia, upper respiratory tract infection, low platelet count (thrombocytopenia) and fatigue






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