Roche gets US FDA approval for Rituxan for follicular lymphoma maintenance; Tarceva meets primary endpoint

Swiss drug major Roche’s (ROG: VX) subsidiary Genentech and Biogen Idec (Nasdaq: BIIB) on Friday received US Food and Drug Administration approval for Rituxan (rituximab) as a maintenance treatment for patients with the advanced blood cancer 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. Rituxan, also sold as MabThera for the treatment of rheumatoid arthritis and non-Hodgkin's lymphoma, is already Roche's second-bestselling medicine, with global sales of about $5.9 billion in 2009 and 4.82 billion Swiss francs ($5.02 billion) in the first nine months of 2010. The drug was originated by Biogen.

"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, chief medical officer and head of global product development at Roche, adding: "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."