Celgene’s lung cancer drug granted European orphan drug status

Orphan designation will provide amrubicin with 10 years of marketing exclusivity following marketing approval for the treatment of small cell lung cancer.

Orphan medicinal product designation is granted by the European Commission to provide special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval.

Graham Burton, senior vice president, global regulatory affairs and pharmacovigilance for Celgene, said: “The decision by the European Commission to designate amrubicin hydrochloride an orphan medicinal product continues our efforts to deliver innovative therapies worldwide to patients in areas of great unmet medical need such as solid tumor cancers.”