The new designation comes after the company presented positive results from a phase I/II study of the drug in May 2005.
This fast track designation gives Genmab the opportunity to submit a biologics license application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time.
A BLA is the biologic products’ equivalent to a new drug application (NDA) and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review or accelerated approval of the BLA where the review time would be halved to just six months.
“We are very pleased that HuMax-EGFr has been designated a fast track product and is now poised to move forward to pivotal studies which we hope to begin this year,” said Dr Lisa Drakeman, chief executive officer of Genmab.