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GEN News Highlights : Nov 30, 2010

FDA Rubber-Stamps APP Pharma’s Generic Topotecan for Small Cell Lung and Cervical Cancers

Fresenius Kabi's subsidiary plans immediate launch for competitor of GSK’s Hycamtin.

APP Pharmaceuticals reported FDA approval of its generic injectable topotecan anticancer drug. The Fresenius Kabi Pharmaceuticals subsidiary said it plans to launch the drug immediately. Topotecan for injection is indicated for the treatment of small cell lung cancer after failure of first-line chemotherapy, and for use in combination with cisplatin for stage IV-B and recurrent/persistent cervical cancer that is not curable using surgery and/or radiation therapy.

APP’s topotecan is one of a growing number of generics that are competing directly with GSK’s topotecan drug Hycamtin®, which achieved global sales of £115 million in the first nine months of 2010, down 9% on the equivalent period in 2009. “As one of the first generic entries into the market, APP’s Topotecan for Injection will help reduce the cost of cancer treatment for patients who suffer from cervical and small cell lung cancers,” claims John Ducker, president and CEO at APP.

APP’s topotecan is not the first generic version of Hycamtin to hit the market, however. Teva Pharma’s Topotecan Teva was first authorized in the EU in 1996. Just last month the European Medicines Agency also recommended approving Actavis Group’s generic topotecan, Potactasol.