YondelisTreatment for Soft Tissue Sarcoma
Update: Yondelis (trabectedin) Now FDA Approved - October 23, 2015
Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin
HORSHAM, Pa., April 29, 2011 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P., today announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin for the treatment of women with recurrent ovarian cancer (ROC). The withdrawal is based on the U.S. Food and Drug Administration's (FDA) recommendation that an additional Phase 3 study be conducted to obtain approval.
The NDA was submitted to the FDA in November, 2008. The FDA issued a Complete Response letter in September 2009 and requested additional information, including overall survival data from the pivotal OVA-301 trial and additional clinical pharmacology studies.
The OVA-301 overall survival data will be the subject of a poster presentation on June 5, 2011 at the Annual Meeting of the American Society of Clinical Oncology (ASCO).
The company is evaluating the development program for YONDELIS in recurrent ovarian cancer.
Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., recently initiated a Phase 3 study (SAR-3007) with trabectedin for metastatic L-sarcoma (liposarcoma or leiomyosarcoma).
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 by PharmaMar SAU and Japan, where PharmaMar SAU and Taiho Pharmaceutical CO., LTD. have a licensing agreement to develop and commercialize it. In countries where it has received marketing authorization, trabectedin is marketed as YONDELIS®.
Trabectedin is approved in more than 63 countries globally.
About Centocor Ortho Biotech Products, L.P.
Centocor Ortho Biotech Products, L.P., a Johnson & Johnson Company, redefines the standard of care in immunology, nephrology, and oncology. Built upon a pioneering history, Centocor Ortho Biotech Products harnesses innovations in large and small molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech Products 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.
Posted: April 2011
- FDA Approves Yondelis (trabectedin) for the Treatment of Specific Soft Tissue Sarcomas - October 23, 2015
- U.S. FDA Grants Priority Review for Yondelis (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma - February 3, 2015
- Janssen Submits NDA for Yondelis (trabectedin) for Advanced Soft Tissue Sarcoma - November 24, 2014
- FDA Issues Complete Response Letter For Trabectedin Combined With Doxil - September 10, 2009
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer - November 20, 2008