Genmab's HuMax-EGFr awarded fast track status from FDA
Genmab A/S announced that HuMax-EGFr has been designated a Fast Track Product by the US food and Drug Administration (FDA). 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.
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.
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