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news.US-based Ortho Biotech Products has submitted a new drug application to the FDA for trabectedin when administered in combination with Doxil for the treatment of women with relapsed ovarian cancer.
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If approved, trabectedin combined with Doxil will provide a new, non-platinum treatment option for these patients in the US, said Ortho Biotech.
The application follows the completion of a multicenter, randomized Phase III study, ET743-OVA-301, 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 compared to patients treated with Doxil alone.
Trabectedin is being developed under a license from PharmaMar, and Doxil is marketed by Ortho Biotech Products in the US.
Craig Tendler, vice president of medical affairs, oncology/nephrology at Ortho Biotech Products, said: “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. 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.”