Centocor Ortho’ Response To FDA’ Opinion On Trabectedin

FDA’ Oncologic Drugs Advisory Committee (ODAC) said 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. The statement was based on the data presented to the FDA.

Centocor Ortho Biotech continues to believe that trabectedin has an important role in the treatment of recurrent ovarian cancer. To support its opinion the company said, “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.”

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 new cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata. Under a licensing agreement with PharmaMar SAU of Spain, Centocor Ortho Biotech has worldwide marketing rights for trabectedin except in Europe and Japan, where the product is marketed as Yondelis by PharmaMar SAU.