MEDAREX'S IPILIMUMAB WINS FAST-TRACK DESIGNATION

Medarex announced that the FDA has granted fast-track designation to ipilimumab used in combination with chemotherapy (dacarbazine) in previously untreated (first-line) metastatic melanoma patients. The FDA also has granted fast-track designation to ipilimumab used as a monotherapy in previously treated (second-line) metastatic melanoma patients.

Under the FDA Modernization Act of 1997, designation as a fast-track product means that the FDA has determined that the drug or biologic demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate the clinical development and expedite the review of the product.

Ipilimumab is an investigational fully human antibody against CTLA- 4, a molecule on T-cells that is believed to be responsible for suppressing the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress or eradicate cancer tumors. Ipilimumab is currently under investigation in several trials under Special Protocol Assessment agreements with the FDA for the treatment of metastatic melanoma. Ipilimumab is also being evaluated in multiple Phase II clinical trials to investigate the product's potential activity in other tumor types, as well as in combination with chemotherapy, immunotherapy and vaccines.