FDA approves venetoclax-obinutuzumab for frontline CLL, SLL


  • David Reilly
  • Oncology drug update
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Takeaway
  • On May 15, the FDA approved venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Why this matters
  • A fixed-duration option may help reduce treatment burden for patients.
Study design
  • Approval was based on the CLL14 study of venetoclax+obinutuzumab (VEN+G) vs obinutuzumab+chlorambucil (GClb) in 432 patients with previously untreated CLL and comorbid conditions.
  • Funding: AbbVie Inc; Genentech Inc.
Key results
  • Significant improvement in PFS with VEN+G vs GClb: HR, 0.33; 95% CI, 0.22-0.51 (P<.0001>
  • 85% (95% CI, 79%-89%) overall response with VEN+G vs 71% (95% CI, 65%-77%) with GClb (P=.0007).
  • Minimal residual disease (MRD) negativity:
    • In bone marrow (BM): 57% (95% CI, 50%-64%) with VEN+G vs 17% with GClb (95% CI, 12%-23%); P<.0001.>
    • In peripheral blood (PB): 76% (95% CI, 69%-81%) with VEN+G vs 35% with GClb (95% CI, 29%-42%); P<.0001.>
    • MRD in patients with complete remission:
      • In BM: 69% (95% CI, 59%-78%) with VEN+G vs 45% with GClb (95% CI, 30%-60%); P=.0048.
      • In PB: 87% (95% CI, 79%-93%) with VEN+G vs 62% with GClb (95% CI, 46%-75%); P=.0005.
    • Limitations
      • Open-label study design.
      Click here for full prescribing information

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