Cell Therapeutics said today that it has been informed by FDA that results from a clinical trial of patients with newly-diagnosed lymphoma will be enough to file an application for expanded usage of Zevalin. The Seattle biotech company (NASDAQ: [[ticker:CTIC]]) said it plans to apply for FDA clearance of the expanded use in the fourth quarter. Zevalin is currently approved for relapsed forms of non-Hodgkin’s lymphoma, and the new application, if approved, would allow sale for patients getting first-line treatment. Results from a 414-patient clinical trial of Zevalin in first-line patients showed it could cause complete tumor shrinkage for 76 percent of patients with a single shot.
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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