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J&J Pulls Yondelis NDA For Ovarian Cancer Ahead Of Final Survival Data Release

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Faced with the prospect of having to run an additional Phase III study to secure FDA approval of its oncologic Yondelis (trabectedin), Johnson & Johnson’s Centocor Ortho Biotech Products division decided to withdraw the NDA and is reviewing the drug’s clinical development program in recurrent ovarian cancer.
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