Medarex, Inc. announced on Dec. 7th that the U.S. Food and Drug Administration has agreed to Fast Track consideration of its biologic ipilimumab (also known as MDX-010) for use in combination with chemotherapy as a first-line treatment for metastatic melanoma patients.

The FDA also has agreed to Fast Track consideration of ipilimumab used alone for previously treated (second-line) metastatic melanoma patients. Ipilimumab is a fully human antibody against human CTLA- 4, a molecule on T cells that is believed to be responsible for suppressing the immune response.

Medarex and its partner Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress or eradicate cancer tumors.

The FDA previously had agreed to Fast Track consideration of ipilimumab as a second- line treatment in combination with MDX-1379 (a melanoma peptide vaccine).

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 studies with chemotherapy, immunotherapy and vaccines.

"We are pleased with the Fast Track designations as . . . we believe that ipilimumab has the potential to play an important role in the fight against cancer," said Irwin Lerner, Chairman of the Board of Directors of Medarex.