Nation’s Best-Selling Cancer Drug Earns FDA Approval for Treatment of Rheumatoid Arthritis
The US’s best-selling cancer drug has won federal approval as a treatment for rheumatoid arthritis (RA) for patients for whom older drugs don’t work, Genentech Inc. and Biogen Idec Inc. recently announced.
The drug Rituximab—branded as Rituxan—was previously administered as treatment for non-Hodgkin’s lymphoma.
Georgia Cancer Specialists (GCS) is offering Rituxan to patients with RA at their 28 treatment offices in Metro Atlanta and Central Georgia.
“This is a major breakthrough for patients with RA,” said Dr. Bruce Feinberg, President/CEO of Georgia Cancer Specialists.
Dr. Mansoor Saleh, GCS Director of Clinical Trials, said, “We are very excited to offer this treatment option to so many patients throughout Atlanta and Central Georgia.”
In rheumatoid arthritis, the body’s immune system attacks tissues in the joints, causing inflammation and destroying cartilage, tendons, and bones. It affects 2.5 million Americans, and often causes disabilities.
About Rituxan
- Rituxan is an anti-CD 20 chimeric mouse/human monoclonal antibody approved in 1997 for the treatment of B-cell lymphomas and has since been used in more than 50,000 patients. It is the first monoclonal agent approved for cancer therapy.
- The FDA approved Rituxan for the treatment of severe Rheumatoid Arthritis following successful studies demonstrating responses in patients who had failed previous treatment and received Rituxan in combination with standard methotrexate.
- The proposed mechanism of action of Rituxan appears to be related to the depletion of B-cell that forms in the basis of this immune mediated condition in RA.
- Given these positive findings, it is anticipated that Rituxan can also be successfully used in the treatment of other related auto-immune condition such as Lupus, auto-immune hair loss and other auto-immune skin conditions.
Supporting Data
- In REFLEX, the phase III randomized clinical trial, a significantly higher number of patients with severe RA who received a single treatment (two infusions) of Rituxan along with methotrexate achieved clinical benefit compared to patients taking placebo and methotrexate.
- At 24 weeks Rituxan patients had significant improvement in signs and symptoms associated with rheumatoid arthritis, including pain and disability.
How Is Rituxan Administered?
- Rituxan is given to the patient twice as a 1,000 mg IV infusion, separated by two weeks.
- It is given in combination with methotrexate. It has been recommended that the steroid methylprednisolone 200 mg IV be given 30 minutes prior to each infusion.
- The course of treatment can be repeated every 6 to 9 months.
