Trabectedin New Drug Application Withdrawn

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fdalogoCentocor Ortho Biotech Products, LP, announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin (Yondelis) for the treatment of women with recurrent ovarian cancer. The withdrawal is based on the FDA’s recommendation that an additional phase III study be conducted to obtain approval.

The NDA was submitted to the FDA in November 2008. The FDA issued a Complete Response letter in September 2009 and requested additional information, including overall survival data from the pivotal OVA-301 trial and additional clinical pharmacology studies. The OVA-301 overall survival data were the subject of a poster presentation on June 5 at the ASCO Annual Meeting.

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata. The compound is now produced synthetically. Trabectedin binds to the minor groove of DNA and bends it toward the major groove, causing DNA adducts that interfere with cell division and genetic transcription processes and DNA repair machinery. ■




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