FDA approves Rituxan for NH lymphoma

USA-based biotechnology firms Genentech and Biogen Idec say that the US Food and Drug Administration has approved their jointly-developed drug Rituxan (rituximab) for the first-line treatment of large B cell CD20-positive non-Hodgkin's lymphoma. The drug will be prescribed in combination with the standard cyclophosphamide, doxorubicin, vincristine and prednisone therapy, or other anthracycline-based chemotherapy regimens.

The FDA, which has previously approved the product for the treatment of relapsed or refractory forms of the disease, based its approval on data from safety and efficacy studies which provided Rituxan to patients in combination with various accepted drug regimens. Each assessment suggested that the product was more effective than standard therapy in terms of time-to-event and overall survival benefit.

In addition, the compound's safety profile, which the firms say has been established following more than 730,000 patient exposures over eight years of trials, is comparable to other cancer therapies. Adverse reactions to treatment have included; fever, flu-like illness, nausea, urticaria, headache, angioedema and hypotension, all of which were reversible with treatment, said the researchers. Severe, and sometimes fatal, reactions to the drug did occur, but were largely limited to first use of the agent.