Rituxan is already approved to treat patients with moderate to severe cases of the disease who are first treated with methotrexate and another class of anti-rheumatic drugs.
The FDA’s rejection of expanded use noted the risk of a potentially fatal brain disease, progressive multifocal leukeoencephalopathy, for which there is no reliable treatment.
The companies responded that the risk is rare, citing reports of three cases of the disease occurring in 100,000 rheumatoid arthritis patients treated with Rituxan.
Read Genentech’s release on Rituxan.
