FDA Issues Complete Response Letter For Trabectedin Combined With DOXIL

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 11 Sep 2009 - 2:00 PDT

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Centocor Ortho Biotech Products, L.P. announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer. The agency has requested additional information, including overall survival data from the company's ongoing pivotal trial and additional clinical pharmacology studies.

Centocor Ortho Biotech Products continues to believe that trabectedin has an important role in the treatment of patients with ovarian cancer. The company is reviewing the FDA's letter and will respond to the agency's questions as quickly as possible.

The NDA for trabectedin was submitted to the FDA in November 2008.

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, where the product is marketed as YONDELIS(R) by PharmaMar SAU and Japan, where PharmaMar SAU and Taiho Pharmaceutical CO., LTD. have a licensing agreement to develop and commercialize YONDELIS.

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.

Source: Centocor Ortho Biotech Products, L.P