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news.Centocor Ortho Biotech Products, a Johnson & Johnson company, has voluntarily pulled back its new drug application (NDA) for trabectedin as a treatment for women who are suffering from recurrent ovarian cancer (ROC).
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Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata.
The company’s decision was based on the US Food and Drug Administration’s (FDA) recommendation for conducting an additional Phase 3 study to obtain approval.
Centocor Ortho signed an agreement with PharmaMar SAU, under which Centocor Ortho has worldwide marketing rights for trabectedin except in Europe and Japan.
Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, has recently initiated a Phase 3 study (SAR-3007) with trabectedin for metastatic L-sarcoma (liposarcoma or leiomyosarcoma).