Ortho Biotech recently announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for trabectedin (Yondelis) when administered in combination with liposomal doxorubicin(Drug information on doxorubicin) (Doxil) for the treatment of women with relapsed ovarian cancer. If approved, trabectedin combined with Doxil will provide a new, nonplatinum treatment option for these patients in the United States.
The application follows the completion of a multicenter, randomized phase III study, ET743-OVA-301, which compared 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.
