In combination with chemotherapy, Genentech’s Gazyva demonstrated a positive response in patients.

Follicular lymphoma is the most common form of non-Hodgkin’s lymphoma (NHL). In efforts to treat the disease, Genentech announced that the FDA has approved its new first-line therapy Gazyva^® (obinutuzumab) in combination with chemotherapy (followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).

The approval, said Genentech, is based on results from its Phase III GALLIUM study, which demonstrated superior progression-free survival (PFS) for patients who received the approved Gazyva-based regimen compared to patients receiving a Rituxan^® (rituximab)-based regimen as a first-line therapy.

According to the company, Gazyva is a monoclonal antibody (mAb) engineered to attach to a particular protein found on certain types of B-cells called CD20. It works by attacking targeted cells directly and through the immune system. Gazyva was originally discovered by Roche Glycart, the independent research unit of Roche.

The GALLIUM study demonstrated a Gazyva-based regimen significantly reduced the risk of disease progression or death by 28%, in comparison with a Rituxan-based regimen. The most common side effects, said the company, (occurring in at least 20%of patients and observed at least 2% more frequently in the Gazyva trial) included infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea.

Chief Medical Officer and Head of Global Product Development for Genentech Sandra Horning said, “Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible,” said. “We’re pleased we can now offer patients with this incurable blood cancer an initial treatment option shown to improve upon Rituxan, the standard of care in this setting for more than 10 years.”