Celgene’s Amrubicin granted orphan drug status

Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. The US orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.

Graham Burton, senior vice president, global regulatory affairs and pharmacovigilance for Celgene, said: “The decision by the FDA to grant Amrubicin orphan drug designation in this critical area of oncology advances our efforts to deliver innovative therapies to patients in areas of unmet medical need and represents the first such milestone in the area of solid tumor cancers.”