FDA Okays Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukaemia

By Reuters Staff

May 17, 2019

ZURICH (Reuters) - Roche said on Thursday that the U.S. Food and Drug Administration had approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (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," Roche's Chief Medical Officer Sandra Horning said in a statement.

The approval is based on the results of the randomised 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 by 67% compared to Gazyva plus chlorambucil, a current standard-of-care, the company said in a news release.

Venclexta plus Gazyva showed clinically meaningful responses characterised 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%). 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 next month at the American Society of Clinical Oncology Annual Meeting.

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