Genentech, a member of the Roche Group, and Biogen Idec today announced the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy (induction treatment). This milestone follows the clearance of Rituxan for this indication by the European Commission in October 2010.
"This approval is important because it shows that maintenance treatment with Rituxan, after initial therapy with Rituxan and chemotherapy, further reduces the risk of relapse in people with follicular lymphoma," said Hal Barron, M.D., chief medical officer and head, Global Product Development, Roche. "Maintenance use of Rituxan offers people with this incurable disease the opportunity to live longer without their disease getting worse, a primary goal of treatment."
Follicular lymphoma is considered incurable and is characterized by periods of relapse and remission over a number of years. This approval, based on the Primary Rituxan and Maintenance (PRIMA) study, showed continuing Rituxan administration every two months for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, nearly doubled the likelihood of them living without the disease worsening (progression-free survival or PFS) compared to those who stopped treatment (based on a hazard ratio of 0.54, 95 percent CI, 0.42-0.70; p≤0.0001).