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Centocor pulls cancer drug application

Centocor has decided not to pursue US approval of ovarian cancer drug trabectedin, with the FDA stating that the company would need to conduct an additional phase III clinical trial before approval could be granted

Centocor Ortho Biotech Products has decided not to pursue US marketing approval of its ovarian cancer drug trabectedin at the current time based on feedback from the US Food and Drug Administration (FDA) that the company would need to conduct at least one additional phase III clinical trial before approval could be granted.

Centocor said it is voluntarily withdrawing its new drug application (NDA) for the drug, which had sought approval for the treatment of women with recurrent ovarian cancer (ROC).

The company submitted the NDA in late 2008 and received a complete response letter from the FDA in September 2009 that requested additional clinical pharmacology studies, among other information.

Centocor, which holds worldwide rights to trabectedin except in Europe and Japan, said it is evaluating the development programme for the drug in ROC.

The product is licensed from the Spanish pharmaceutical company PharmaMar SAU, which markets the drug itself in Europe and is developing the product through a partnership with Taiho Pharmaceutical in Japan.

Trabectedin is approved in more than 63 countries globally under the trade name Yondelis.

Early last year, the National Institute for Health and Clinical Excellence (NICE) recommended the use of Yondelis on the NHS for the treatment of advanced soft tissue sarcoma. The recommendation came after previous draft guidance from NICE in 2009 which did not recommend Yondelis due to its high cost.

PharmaMar addressed those concerns by offered to cover further costs for any patient who needs it beyond five treatment cycles under NICE's Patient Access Scheme.

The drug, which works by attacking the DNA in cancer cells to stop growth and spreading, would be the first new treatment for this group of rare cancers for more than 25 years. Current treatments, including traditional chemotherapies, achieve a poor response in advanced forms of the disease and survival rates remain low.

3rd May 2011

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