Based on the data presented, the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of trabectedin when administered with Doxil (doxorubicin HCI liposome injection) did not provide a sufficient benefit-risk profile for the treatment of relapsed ovarian cancer.

Ovarian cancer is difficult to treat and the disease often recurs in patients who previously have been treated with platinum-based therapy, underscoring the need for non-platinum treatment options. Centocor Ortho Biotech Products continues to believe trabectedin has an important role in the treatment of recurrent ovarian cancer. The company remains committed to working with the FDA to address the committee's concerns.

The committee provides non-binding recommendations based on its evaluation. The final decision regarding approval of the drug will be made by the FDA.

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata.