Seattle Genetics, the Bothell, WA-based cancer drug developer, said today it has received “Fast Track” designation from the FDA for the pivotal trial of its SGN-35 drug for Hodgkin’s disease. The designation, which the FDA provides to potentially life-saving therapies, will allow Seattle Genetics (NASDAQ: [[ticker:SGEN]]) to submit data in its application on a rolling basis as it becomes available. The company still hopes to turn in its application to the FDA in 2011, although it has potential for an expedited six-month regulatory review instead of the usual 10 months.
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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