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FDA grants breakthrough therapy designation to Venclexta-Gazyva combination for untreated chronic lymphocytic leukemia
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The FDA granted breakthrough therapy designation to venetoclax in combination with obinutuzumab as a fixed-duration, first-line regimen for treatment-naive patients with chronic lymphocytic leukemia.
The agency will review this combination under its Real-Time Oncology Review pilot program, designed to improve efficiency of the review process so effective, safe treatments can be made available to patients as soon as possible.
Venetoclax (Venclexta; AbbVie, Genentech) selectively binds and inhibits the BCL-2 protein. Obinutuzumab (Gazyva, Genentech) is an anti-CD20 monoclonal antibody.
“These medicines, used together, may enable some [patients with CLL] to live longer without their disease getting worse, leading to longer progression-free survival, while remaining off therapy,” Mohamed Zaki, MD, PhD, vice president and global head of hematology development for AbbVie, said in a company-issued press release. “Under the Real-Time Oncology Review program, we are determined to work with the FDA and bring this first- and only-in-class medicine to previously-untreated [patients with CLL] earlier than expected.”
The randomized phase 3 CLL14 trial included 432 patients with treatment-naive CLL.
Researchers randomly assigned patients to a venetoclax-obinutuzumab combination for a fixed duration of 12 months, or the standard regimen of obinutuzumab plus chlorambucil.
This was the first randomized trial to examine a chemotherapy-free, fixed-duration treatment regimen for CLL.
As HemOnc Today previously reported, the trial met its primary endpoint of improved PFS among patients assigned the venetoclax-obinutuzumab combination. The combination exhibited a safety profile consistent with the known profiles of each agent alone.
“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 at Genentech, said in a company-issued press release. “We are encouraged that this chemotherapy-free, fixed-duration combination is being reviewed under the FDA’s Real-Time Oncology Review pilot program, and we are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukemia as quickly as possible.”