FDA gives Rituxan priority review
Genentech Inc. and Biogen Idec Inc. said on Tuesday their cancer drug Rituxan will get a speedy review from U.S. regulators for the treatment of aggressive, but previously untreated non-Hodgkin's lymphoma.
Genentech and Biogen Idec already sell Rituxan as a treatment for non-Hodgkin's lymphoma. The companies are seeking approval for the drug as a first-line therapy for patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma (NHL), in combination with chemotherapy.
The drug has been granted priority review status, giving the U.S. Food and Drug Administration up to six months to take action on the application, which was submitted on Aug. 12.
Currently, more than 360,000 people in the United States live with NHL. About half have the aggressive form. (Reuters)
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