Roche and AbbVie’s Venclexta (venetoclax) + Gazyva (obinutuzumab) Receive FDA’s Approval for Untreated Chronic Lymphocytic Leukemia


  • The approval is based on the P-III CLL14 study results assessing Venclexta + Gazyva vs Gazyva + chlorambucil in 432 patients with previously untreated CLL for 12mos.
  • The P-IIICLL14 study results: rate of MRD-negativity in the bone marrow & peripheral blood (57% vs. 17% & 76% vs. 35%); reduction in PFS (67%); ORR (85% vs 71%); presented at ASCO in Jun’19
  • Venclexta targets BCL-2 protein to restore the process of apoptosis, co-developed & co-commercialized by AbbVie and Roche and Gazyva is a mAb targeting CD20 to destroy B-cells both directly and together with the body’s immune system. The combination receives FDA’s BT designation for previously untreated CLL with co-existing medical conditions

Click here to read full press release/ article | Ref: Roche | Image: PBS