Swiss drugmakers Roche concluded their two-year study of a new drug called Gazyva (Gazyvaro in the European Union and Switzerland). The study ended earlier than originally planned due to the obvious and significant benefits of the drug. Patients who were treated with Gazyva lived considerably longer compared with the control group, who was treated only with bendamustine, a standard chemotherapy drug given to many cancer patients.
Researchers said there were no unexpected adverse side effects.
“We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose Rituxan-based therapy failed to adequately control their disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development at Roche.
The study was conducted on 413 patients whose indolent Non-Hodgkin’s lymphoma had worsened during or after Rituxan-based therapy (a widely used treatment of Non-Hodgkin’s lymphoma). Patients were given Gazyva in combination with bendamustine, then Gazyva alone.
There are two main kinds of lymphoma: Hodgkin’s and Non-Hodgkin’s. Non-Hodgkin’s lymphoma makes up approximately 85 percent of all lymphoma cases. In the United States, almost 72,000 people are afflicted with Non-Hodgkin’s lymphoma. American Cancer Society predicts that this year alone, 20,000 people will die from the disease.
Non-Hodgkin’s lymphoma affects the B-lymphocytes, a key component in the body’s immune system. As the cancer develops, these B-cells begin to multiply out of control and accumulate around the lymph nodes and lymphatic tissues.
Gazyva has been designed to attach to a protein found exclusively in B-cells. In this way, the drug can attack the affected cells directly. More importantly, Gazyva encourages the body’s native antibodies to attack B-cells.
Researchers believe Gazyva promotes greater activity in the immune system than Rituxan. However, further clinical studies must be done to know for sure. Roche is currently conducting a larger study which compares the use of Gazyva and chemotherapy to treat patients with Non-Hodgkin’s lymphoma with the use of Rituxan and chemotherapy.
The research of this study will be presented to the Food and Drug Administration, as well as the European Medicines Agency and other health authorities, to be considered for approval.
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