Chemotherapy-Free Combo Treatment for CLL Granted Breakthrough Designation


The supplemental new drug application for venetoclax in combination with obinutuzumab is being reviewed under the FDA’s Real-Time Oncology Review pilot program for patients with previously-untreated chronic lymphocytic leukemia.

Officials with the FDA have granted Breakthrough Therapy Designation to venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for patients with previously-untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions, according to a press release.

This is the fifth Breakthrough Therapy Designation for venetoclax, which is being studied across a range of blood cancers. Venetoclax has also been approved for the treatment of previously-treated adults with CLL or small lymphocytic lymphoma and in combination with azacytidine, decitabine, or low-dose cytarabine for certain adults with newly-diagnosed acute myeloid leukemia.

“More than 20,000 people will be diagnosed with untreated chronic lymphocytic leukemia in the United States this year, and many are ineligible for intensive chemotherapy-based options,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a statement.

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

The designation was based on data from the phase 3 CLL14 study. The trial evaluated the fixed-duration combination therapy compared with standard-of-care obinutuzumab plus chlorambucil in 432 patients with previously-untreated CLL and comorbidities.

According to the data, venetoclax and obinutuzumab significantly reduced the risk of disease worsening or death compared with obinutuzumab plus chlorambucil, meeting the trial’s primary endpoint. In the study, the therapies were administered for a 12-month fixed duration of venetoclax in combination with 6 cycles of obinutuzumab. Secondary endpoints included progression-free survival assessed by independent review committee, best overall response, complete response, duration of response, overall survival, event-free survival, time to next CLL treatment, minimal residual disease status, and safety.

Additionally, the results showed no new safety signals or increase in known toxicities of venetoclax or obinutuzumab in the treatment combination.

Data from the CLL14 study will be presented at an upcoming medical meeting, according to Genentech.

The FDA is reviewing the supplemental new drug application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The combination therapy is being jointly developed by AbbVie and Genentech, a member of the Roche Group.


Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions [news release]. Genentech. Accessed March 7, 2019.

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