The FINANCIAL — Roche (SIX: RO, ROG; OTCQX: RHHBY) on January 31 announced that the U.S. Food and Drug Administration (FDA) approved Rituxan/MabThera (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan/MabThera plus chemotherapy (induction treatment).
This milestone follows the clearance of MabThera for this indication by the European Commission in October 2010.
“This approval is important because it shows that maintenance treatment with Rituxan/MabThera after initial therapy with Rituxan/MabThera and chemotherapy, further reduces the risk of relapse in people with follicular lymphoma,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. “Maintenance use of Rituxan/MabThera 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 characterised by periods of relapse and remission over a number of years. This approval, based on the PRIMA study, showed continuing Rituxan/MabThera administration every two months for two years in patients who responded to initial treatment with Rituxan/MabThera plus chemotherapy, nearly doubled the likelihood of them living without their disease worsening (progression-free survival or PFS) compared to those who stopped treatment (based on a hazard ratio of 0.54, 95% CI, 0.42–0.70; p<=0.0001).
According to the American Cancer Society, an estimated 574,000 Americans are living with non-Hodgkin’s lymphoma (NHL). Approximately 65,540 Americans will have been newly diagnosed with NHL in the United States in 2010. Of those diagnosed with NHL, 1 in 5 patients will have follicular lymphoma.
Discussion about this post