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# FDA OKs Genentech Combo for Leukemia/Lymphoma
- URL: https://www.fdaweb.com/fda-oks-genentech-combo-for-leukemia-lymphoma/
- Published: 2019-05-15T12:00:00.000Z
- Updated: 2026-09-15T01:26:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144117

FDA has approved a Genentech supplemental NDA for Venclexta (venetoclax) in combination with the company’s Gazyva (obinutuzumab) for treating people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Approval is based on data from the Phase 3 CLL14 study, which evaluated a 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. “Results showed the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival (PFS), as assessed by independent review committee) by 67% compared to Gazyva plus chlorambucil, a current standard of care...,” the company says.

Genentech also says that in the study, Venclexta plus Gazyva showed “deep and clinically meaningful responses characterized by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared to Gazyva plus chlorambucil (MRD-negativity of 57% vs. 17%) and peripheral blood (MRD-negativity of 76% vs. 35%).

The most common adverse reactions with Venclexta plus Gazyva were low white blood cell count, diarrhea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.