Biotech, cancer, FDA
Seattle Genetics Gets Fast Track
Luke Timmerman 3/30/09
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: 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.
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.
