Ovarian Cancer

Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin

Published in Women's Health Weekly, May 19th, 2011

2011 MAY 19 -- Centocor Ortho Biotech Products, L.P., announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin for the treatment of women with recurrent ovarian cancer (ROC).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...

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Source: Women's Health Weekly (2011-05-19)

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