Genmab's HuMax-EGFr gets FDA fast track status for head, neck cancer

By Angela McDaniels

Seattle, Jan. 3 - Genmab AS said the Food and Drug Administration has granted fast track designation to HuMax-EGFr for the treatment of patients with head and neck cancer who have previously failed standard therapies.

This fast track designation gives Genmab the opportunity to submit a Biologics License Application in sequential sections and have these sections reviewed as they are submitted.

A Biologics License Application is the biologic products' equivalent to a New Drug Application and is the final stage before a drug is approved for the market.

Under the fast track designation, a drug may also receive a priority review or accelerated approval in six months instead of 12.

HuMax-EGFr is a fully human, high-affinity antibody that targets the epidermal growth factor receptor found on the surface of many cancer cells, thus slowing tumor growth, the company said.

Copenhagen-based Genmab AS is a biotechnology company that develops human antibodies for the treatment of life-threatening and debilitating diseases.

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