Medarex' MDX-010 granted Orphan Drug Status

Medarex' MDX-010 has been granted Orphan Drug Designation in the USA for the treatment of high-risk stage II, stage III and stage IV melanoma. The US firm intends to initiate a pivotal study of the fully-human anti-CTLA-4 antibody in the second half of this year, pending approval of a Special Protocol Assessment filed with the US Food and Drug Administration. Positive data from a Phase II evaluation of the drug as a single agent and in combination with dacarzabine were presented at the recent American Society of Clinical Oncology meeting in New Orleans.