Combination Therapy Granted FDA Approval for Untreated Chronic Lymphocytic Leukemia

The combination therapy received Breakthrough Therapy designation in March 2019 for previously-untreated CLL.

Venetoclax (Venclexta, AbbVie and Genentech) in combination with obinutuzumab (Gazyva, Genentech) received FDA approval today for previously-untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to a press release.

The combination therapy received Breakthrough Therapy designation in March 2019 for previously-untreated CLL. Venetoclax has already been approved for previously-treated adults with CLL or SLL and in combination with azacytidine, decitabine, or low-dose cytarabine for certain adults with newly-diagnosed acute myeloid leukemia.

Although signs of CLL may disappear after initial treatment, the disease is considered incurable and patients typically require additional treatment when cancer cells return, according to Genentech. Non-chemotherapy treatments are needed to provide additional options for patients who cannot tolerate chemotherapy-related adverse effects.

“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, MD, chief medical officer and head of Global Product Development, Genentech, said in a statement. “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.”

Results of the phase 3 CLL14 study demonstrated that the combination regimen produced a durable and significant reduction in the risk of disease worsening or death. The trial evaluated 12-month, fixed-duration treatment with venetoclax plus obinutuzumab compared with obinutuzumab plus chlorambucil in 432 patients with previously-untreated CLL. Patients received either a 12-month duration of venetoclax plus obinutuzumab alongside a 6-month duration of obinutuzumab or 6-month duration of obinutuzumab plus chlorambucil followed by an additional 6-month duration of chlorambucil.

According to the data, venetoclax plus obinutuzumab reduced the risk of disease worsening or death compared with obinutuzumab plus chlorambucil by 67%. Additionally, the venetoclax plus obinutuzumab regimen showed deep and clinically meaningful responses characterized by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared with obinutuzumab plus chlorambucil (MRD-negativity of 57% versus 17%) and peripheral blood (MRD-negativity of 76% versus 35%), according to the study.

These study results will be presented at the upcoming American Society of Clinical Oncology Annual Meeting in June 2019.

The most common adverse effects associated with venetoclax plus obinutuzumab were low white blood cell count, diarrhea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.


Genentech Announces FDA Approval for Venclexta plus Gazyva for People With Previously Untreated Chronic Lymphocytic Leukemia [news release]. Genentech. Accessed May 15, 2019.

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