Centocor Ortho Biotech Statement On The FDA ODAC Opinion Regarding Trabectedin For Relapsed Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Jul 2009 - 2:00 PDT

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Based on the data presented, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of trabectedin when administered with DOXIL(R) (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.

About Trabectedin

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata. The compound is now produced synthetically. Trabectedin binds to the minor groove of DNA and bends it toward the major groove, causing DNA adducts that interfere with cell division and genetic transcription processes and DNA repair machinery. Under a licensing agreement with PharmaMar SAU of Spain, Centocor Ortho Biotech Products, L.P. has worldwide marketing rights for trabectedin except in Europe and Japan, where the product is marketed as YONDELIS(R) by PharmaMar SAU.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech redefines the standard of care in immunology, nephrology, and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Products, L.P. were consolidated in late 2008, and was renamed Centocor Ortho Biotech. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care.

Centocor Ortho Biotech Products, L.P. is a member of the Johnson & Johnson Family of Companies.

Source: Centocor Ortho Biotech Products, L.P