September 5, 2008
Celgene Receives FDA Fast Track Designation for Lung Cancer Drug
Celgene, which discovers, develops and commercializes therapies for the treatment of cancer and inflammatory diseases, has announced that Amrubicin has been granted fast track product designation by the FDA for the treatment of small cell lung cancer after first-line chemotherapy.
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."