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FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL

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

The approval is based on the results of the randomized phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with venetoclax plus obinutuzumab compared to obinutuzumab plus chlorambucil. Results showed the combination of venetoclax plus obinutuzumab produced a durable and significant reduction in the risk of progression-free survival, as assessed by independent review committee, by 67% compared to obinutuzumab plus chlorambucil, a current standard of care (hazard ratio [HR] = 0.33; 95% confidence interval [CI] = 0.22-0.51; < .0001).

In addition, venetoclax plus obinutuzumab showed deep and clinically meaningful responses characterized by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared to obinutuzumab plus chlorambucil (MRD-negativity of 57% vs 17%) and peripheral blood (MRD-negativity of 76% vs 35%). 

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

The most common adverse reactions with venetoclax plus obinutuzumab 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 under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programs. 

View updated highlights of the prescribing information for venetoclax plus obinutuzumab.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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