Centocor Ortho Biotech Products, LP has received a Complete Response letter from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with Doxil (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer. The agency has requested additional information, including overall survival data from the company's ongoing pivotal trial and additional clinical pharmacology studies.
Centocor Ortho Biotech Products continues to believe that trabectedin has an important role in the treatment of patients with ovarian cancer. The company is reviewing the FDA's letter and will respond to the agency's questions as quickly as possible.
The NDA for trabectedin was submitted to the FDA in November 2008.
Trabectedin is a novel cytotoxic anti-tumour agent that was originally derived from the marine tunicate, Ecteinascidia turbinata.
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