Amrubicin Receives FDA Orphan Drug Designation for the Treatment of Small Cell Lung Cancer

27-Mar-2008

Celgene Corporation announced that Amrubicin has been granted Orphan Drug Designation by the U.S. food and Drug Administration (FDA) for the treatment of small cell lung cancer.

"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," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. "We will continue to work diligently with regulators as we advance this promising next generation anthracycline through clinical development."

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 and breast cancers.

Amrubicin is currently approved and marketed in Japan for the treatment of small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of the therapy. Dainippon Sumitomo also licensed the U.S. and European rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in 2008.

https://www.chemeurope.com/en/news/80086/amrubicin-receives-fda-orphan-drug-designation-for-the-treatment-of-small-cell-lung-cancer.html