FDA to speed ruling on uses of Biogen cancer drug

The Food and Drug Administration will give speedy review to Biogen Idec Inc.'s request that Rituxan, its treatment for a specific type of non-Hodgkin's lymphoma, be used to treat another form of the disease.

The Cambridge biotechnology company said the FDA will answer by mid-February the request to add the new indication to Rituxan's label, about six months from the time of the submission.

Rituxan was developed by Idec Pharmaceuticals Inc. before it merged with Biogen Inc. in 2003. The drug was approved for sale in the United States in 1997 and is the core of Biogen Idec's cancer-drug franchise, which the company is hoping to grow. It is also conducting trials to show Rituxan is an effective treatment for cancers similar to non-Hodgkin's lymphoma.

A favorable ruling on the request is not expected to have a major impact on Biogen Idec, as many physicians already prescribe Rituxan for such ''off-label" uses. In the second quarter of the year, US sales of Rituxan were $450 million, compared to $390 million in the same period last year. Biogen Idec co-markets the drug with Genentech Inc. of South San Francisco and shares revenues with the larger company.

Biogen Idec is also seeking FDA approval to sell Rituxan as a treatment for rheumatoid arthritis. A preliminary ruling on whether that application will be accepted for review by the agency is expected within weeks. If the application is ultimately approved, it could dramatically increase sales of Rituxan.

Separately, Biogen Idec is anticipating a ruling from the FDA during the first half of 2006 regarding its multiple sclerosis drug Tysabri, which was pulled off the market in February. The company hopes to restart sales of the drug.

Jeffrey Krasner can be reached at krasner@globe.com.