Centocor Ortho Biotech Products, L.P., today announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin for the treatment of women with recurrent ovarian cancer (ROC).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).
Centocor Ortho Biotech Products, L.P.