Zevalin Gets 6-Month FDA Review
Seattle-based Cell Therapeutics said its drug for non-Hodgkin’s lymphoma is getting a faster-than-usual regulatory review of an application that could broaden its usage. The FDA is giving a six-month review, instead of the usual 10-month examination, to ibritumomab tiuxetan (Zevalin) for newly diagnosed patients with Hodgkin’s disease. That means the agency has a deadline of April 2 to decide whether to approve marketing of the drug for the new use. The treatment is currently cleared for sale among relapsed patients, but the new application could open usage of the treatment for an additional 18,000 patients a year, the company said.