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news.Zeltia, a Spain-based holding company, has announced that its subsidiary PharmaMar, a biotechnology company, has submitted a registration dossier to the European Medicines Agency for Yondelis when administered in combination with Doxil and Caelyx for the treatment of women with relapsed ovarian cancer.
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If approved, Yondelis combined with Doxil and Caelyx will provide a new, non-platinum treatment option for these patients in Europe. The application follows the completion of a multicenter, randomized Phase III study, OVA-301, one of the largest studies said to be conducted in relapsed ovarian cancer, comparing the combination of Yondelis and Doxil and Caelyx to Doxil and Caelyx alone in 672 patients.
According to the company, 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 and Caelyx alone.
Yondelis is developed under an agreement between PharmaMar and Ortho Biotech Products, a subsidiary of Johnson & Johnson. Pursuant to the terms of the agreement, PharmaMar has the rights to market Yondelis in Europe (including eastern Europe) and Japan while Ortho Biotech Products has rights to market Yondelis in the rest of the world.