The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
Genentech’s combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) won approval from the U.S. Food and Drug Administration (FDA) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The combination treatment was approved under the FDA’s new Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs. This is the second approval Genentech has won under the FDA’s pilot program. Earlier this month, the company’s breast cancer treatment Kadcyla won approval as adjuvant treatment of people with HER2-positive early breast cancer.
The combination of Venclexta and Gazyva was approved based on results from the Phase III CLL14 trial that showed 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil, a current standard of care for these blood cancers. Results of the Phase III trial showed the combination treatment produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival (PFS) by 67%. Additionally, the combination of Venclexta and Gazyva produced “deep and clinically meaningful responses” that were characterized by a high rate of minimal residual disease (MRD)-negativity in the bone marrow compared to the standard of care. The MRD-negativity was 57% to 17%, the company said. Mrd-negativity in peripheral blood was 76% vs. 35%, the company added. 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.
“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,” Sandra Horning, chief medical officer and head of Global Product Development at Genentech said in a statement.
Horning added that the FDA’s approval represents the company’s “long-standing commitment to helping people with blood cancers throughout the course of their disease.” She also said the company was excited to provide this new option for untreated chronic lymphocytic leukemia. CLL is the most common type of adult leukemia. In the United States, it is estimated that more than 20,000 new cases of CLL will be diagnosed in 2019.
Venclexta, which is being co-developed with Illinois-based AbbVie, is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. Gazyva is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system.
