Genentech Announces FDA Approval for Venclexta Plus Gazyva for People with CLL

Genentech announced the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

"Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard of care," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukemia."

The approval is based on the results of the randomized Phase III CLL14 study, which evaluated 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 percent compared to Gazyva plus chlorambucil, a current standard of care (HR=0.33; 95 percent CI 0.22-0.51; p<0.0001). 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 percent vs. 17 percent) and peripheral blood (MRD-negativity of 76 percent vs. 35 percent). MRD-negativity means no cancer can be detected using a specific and highly sensitive test, defined as less than one CLL cell in 10,000 white blood cells.

Results of the study will be presented at the American Society of Clinical Oncology Annual Meeting in June 2019. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, M.D., University of Cologne.

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.

The FDA rapidly reviewed and approved the supplemental New Drug Application (sNDA) under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs. This is the second regimen of Genentech medicines approved under the RTOR pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The sNDA was also granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA previously granted Breakthrough Therapy Designation for Venclexta in combination with Gazyva for the treatment of previously untreated CLL with co-existing medical conditions. Additional submissions of the CLL14 data to health authorities around the world are ongoing.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

The combination of Venclexta and Gazyva is taken for a fixed duration unlike some other cancer medicines that are taken until disease progression. For those who qualify, Genentech offers patient assistance programs for people prescribed Venclexta and Gazyva by their doctor through Genentech Access Solutions.

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