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

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.

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

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.

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

Faced with the prospect of having to conduct another Phase III study, Johnson & Johnson opted to withdraw the trabectedin application and is reviewing the drug's clinical development program in recurrent ovarian cancer.

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