Ortho Biotech files trabectedin NDA

Ortho Biotech Products, part of the US drug major Johnson & Johnson, has filed a New Drug Application with the Food and Drug Administration for trabectedin when administered in combination with Doxil (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer. If approved, trabectedin combined with Doxil will provide a new, non-platinum treatment option for these patients in the USA.

The application follows the completion of a multicenter, randomized Phase III trial, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination to Doxil alone in 672 patients. This showed that patients treated with the combination therapy had a statistically-significant improvement in the primary endpoint of progression-free survival compared to those on 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, at Ortho Biotech Products.