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.
Author: Luke Timmerman
Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.
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