Genmab A/S has announced that HuMax-CD4 has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with cutaneous T-cell lymphoma (CTCL) who have failed currently available therapy. This patient group includes those who are refractory as well as those who cannot tolerate currently available treatment. HuMax-CD4 is currently in two Phase II studies to treat CTCL.
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical needs for such a condition.
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 of the BLA where the review time would be halved to just 6 months.
"Fast Track status confirms there is a major unmet medical need for treatment of CTCL patients," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We are encouraged by the results of the clinical trials to date and are looking forward to continued development."