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withdrawn the New Drug Application (NDA) for trabectedin for the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).
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 by PharmaMar SAU and Japan, where PharmaMar SAU and Taiho
Pharmaceutical CO., LTD. have a licensing agreement to develop and
commercial
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