Common rheumatoid arthritis drug receives FDA approval to treat certain follicular lymphoma patients.
may now be used as as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy (induction treatment).
The FDA approved the new use following the clearance of Rituxan for this indication by the European Commission in October 2010. Genentech, a member of the Roche Group, and Biogen Idec manufactures Rituxan.
"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," Hal Barron, MD, chief medical officer and head, Global Product Development, Roche, said in a press release. "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.
PRIMA is an international, multicenter, randomized, phase III clinical study that enrolled 1,217 patients with previously untreated advanced follicular lymphoma. The study evaluated the efficacy and safety profile of maintenance Rituxan in patients who achieved a response (complete or partial) to Rituxan in combination with chemotherapy.
Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In NHL and rheumatoid arthritis (RA), Rituxan works with the body's own immune system to eliminate marked CD20-positive B-cells. Stem cells (B-cell progenitors, those cells that give rise to B-cells) in bone marrow do not have the CD20 protein. B-cells usually regenerate after Rituxan treatment and return to normal levels in about 12 months for most patients.
Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the European Union under the trade name MabThera in June 1998.
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