Rituxan is currently only approved for treatment of patients who have not been helped by other treatments for the disease. The companies are now asking that the drug be granted approval for use as a first treatment for intermediate and aggressive forms of the disease, in combination with standard treatments for the condition.
As part of this filing, the companies have requested priority review designation from the FDA. If the drug is granted this designation, the FDA will have to review the application within a six month period.
The filing was based on the results of phase III trials in more than 1,800 patients.
“These three phase III studies add to the body of data regarding Rituxan in the treatment of non-Hodgkin’s lymphoma,” said Dr Hal Barron, Genentech senior vice president, development and chief medical officer. “We are pleased to be filing these data with the FDA, and we are committed to working closely with the agency during the review process.”