Genmab's HuMax-EGFr has been designated a fast track product by the US Food and Drug Administration. This designation covers patients with head and neck cancer who have previously failed standard therapies. Genmab presented positive results from the phase I/II study of HuMax-EGFr in May 2005.

According to a company release, 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 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 6 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 Lisa N. Drakemanm, chief executive officer of Genmab.

HuMax-EGFr is a fully human, high-affinity antibody targeted at the Epidermal Growth Factor receptor (EGFr). EGFr is a receptor molecule found on the surface of many cancer cells. Activation of EGFr by the appropriate growth factor molecule promotes the growth of tumor cells.

In September 2003, Genmab initiated an open label Phase I/II clinical trial using HuMax-EGFr to treat patients suffering from confirmed recurrent or metastatic squamous cell carcinoma of the head and neck who had previously failed standard therapies.