Ortho Biotech Products, L P announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for trabectedin when administered in combination with Doxil (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with Doxil will provide a new, non-platinum treatment option for these patients in the United States.
The application follows the completion of a multicenter, randomized phase-III study, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination of trabectedin and DOXIL to DOXIL alone in 672 patients. The study showed that patients treated with the combination treatment had a statistically significant improvement in the primary endpoint of progression-free survival (PFS, or the length of time during and after treatment in which the disease does not progress) compared to patients treated with Doxil alone.
"This is a significant milestone in the development of trabectedin, an agent with a novel mechanism of action that holds promise for patients with relapsed ovarian cancer," said Craig Tendler, vice president, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products. "We are confident in the strength of the data supporting the application and look forward to working with the FDA throughout the regulatory review process."
Relapsed ovarian cancer refers to epithelial carcinoma of the ovary that recurs after treatment. According to the National Cancer Institute (NCI), it is estimated that 21,650 women will be diagnosed with, and 15,520 women will die from ovarian cancer in the US in 2008.
Trabectedin is being developed under a license from PharmaMar, and Doxil is marketed by Ortho Biotech Products, LP in the US.
Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the Caribbean tunicate, Ecteinascidia turbinate (sea squirt).
Ortho Biotech Products is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease.