Two In One Day: Centocor Ortho Biotech Gets Complete Response Letters For Doxil In Breast Cancer And Yondelis In Ovarian Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
For Yondelis, FDA has requested mature overall survival data from an ongoing pivotal trial. For Doxil, it is likely another trial will be necessary.
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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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