Celgene receives FDA fast track designation for lung cancer drug

Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin has been granted orphan-drug designation for the treatment of small cell lung cancer in both the US and EU.

Graham Burton, senior vice president of global regulatory affairs and pharmacovigilance at Celgene, said: “This designation is another example of the increasing focus on the clinical potential of Amrubicin as a treatment for small cell lung cancer. It further validates the considerable scientific data being presented at major medical meetings for this critical disease.”