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

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

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

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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