Genmab A/S announced that HuMax-CD20 has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with chronic lymphocytic leukaemia (CLL) who have failed fludarabine therapy. This patient group includes those who are refractory to available treatment. HuMax-CD20 is currently in two Phase I/II studies to treat CLL and Non-Hodgkin's Lymphoma (NHL).
Fast Track Product status allows the FDA to 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 if 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 or accelerated approval of the BLA where the review time would be halved to just 6 months.
"The designation of HuMax-CD20 as a Fast Track Product recognizes the need for new forms of treatment for patients suffering from CLL," said Lisa N Drakeman, Ph.D., chief executive officer at Genmab.
HuMax-CD20 is a human antibody which is effective at binding to the disease target, and releases only very slowly from the target over time. In December 2004 Genmab presented positive data from a Phase I/II trial with patients with relapsed or refractory follicular lymphoma showing 55 per cent of patients treated with HuMax-CD20 achieved a clinical response in the Phase I/II study, including two complete responses and one unconfirmed complete response for a 27 per cent complete response rate. These responses were observed in 11 evaluable patients among the first 15 of the 40 patients included in this study at the week 11 evaluation points.