The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental biologics license application (sBLA) seeking the approval of Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone, for patients with previously untreated follicular lymphoma.
The application was granted priority review, which accelerates the FDA’s review time from 10 to six months. A final decision by the FDA is expected by Dec. 23.
“Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible,” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release. “Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible.”
The sBLA is based on data from the Phase 3 GALLIUM study (NCT01332968), an open-label, multicenter, randomized study designed to assess the safety and effectiveness of Gazyva plus chemotherapy, followed by Gazyva alone for up to two years, versus Rituxan (rituximab) plus chemotherapy, followed by Rituxan alone.
Gazyva reduced the risk of disease progression or death by 32% compared to the Rituxan trial group. This result was confirmed by an independent committee.
The most common adverse events that occurred more frequently in the Gazyva group than in the Rituxan group were low numbers of white blood cells, infections, infusion-related reactions, low numbers of platelets, new tumors, and cardiac events.
Gazyva is also approved in the U.S. in combination with the chemotherapy bendamustine for adults with follicular lymphoma who did not respond to a Rituxan-containing regimen, or who relapsed after treatment. It was also approved by the FDA for patients with previously untreated chronic lymphocytic leukemia.
Like Rituxan, also marketed in the U.S. by Genentech, Gazyva is an engineered monoclonal antibody that binds to CD20. CD20 is present on the surface of B-cells, the white blood cells affected in lymphoma. It targets these cells both directly and indirectly, with the help of the body’s immune system.