Celgene receives FDA 'fast track' for Amrubicin in small cell lung cancer after first-line chemotherapy

Celgene Corporation today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy.

A drug designated as a Fast Track product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to provide a therapy where none exists or provide a therapy which may offer a significant improvement in safety and/or effectiveness over existing therapy. Fast track designation, which was authorized by the FDA Modernization Act of 1997, can potentially facilitate development and expedite the review of an approval application. This fast track status is meant to bring valuable new treatments to the patient earlier.

“This designation is another example of the increasing focus on the clinical potential of Amrubicin as a treatment for small cell lung cancer,” said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. “It further validates the considerable scientific data being presented at major medical meetings for this critical disease.”

Amrubicin is a third-generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti-cancer therapies for a variety of solid tumors, including lung cancer.

Amrubicin is currently approved and marketed in Japan for the treatment of lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo Pharma, the original developer of the therapy. Dainippon Sumitomo Pharma also licensed the North American and European Union rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in March 2008. Amrubicin has been granted orphan-drug designation for the treatment of small cell lung cancer in both the U.S. and European Union.

Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and which occurs almost exclusively in people who smoke. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non-small cell lung cancer. An estimated 65,000 patients are diagnosed with SCLC each year in the US and EU.