U.S. agency puts AMG 706 on fast track

FDA designation speeds development of drug

By Erin Kristoff
Administrative Assistant Life Raft Group

 Amgen’s experimental drug AMG 706 has been granted “fast-track” designation in the United States. “AMG 706, Amgen's first investigational oral cancer therapy, may hold promise for various tumor types and is currently in phase II trials for the treatment of [GIST], a fatal cancer,” said Dr. Beth Seidenberg, chief medical officer and senior vice president of global development at Amgen. “Fasttrack designation represents an important step for [AMG 706] and will help to streamline development.”

Under the U.S. Food and Drug Modernization Act of 1997, the fast-track programs are designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Early clinical data on AMG 706 show signs of solid tumor regression with promising initial safety data. The fast-track designation came Dec. 6.

AMG 706 is in phase two trials for GIST at an expanding number of locations in the United States and abroad. Two phase one clinical trials have been expanded to include GIST patients for whom the experimental Pfizer drug SU11248 failed. Information can be found at the Life Raft Web site, www.liferaftgroup.org.

 These trials do not have a placebo, ensuring that all GIST patients will receive the actual drug.