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.
You may also be interested in...
Two In One Day: Centocor Ortho Biotech Gets Complete Response Letters For Doxil In Breast Cancer And Yondelis In Ovarian Cancer
For Yondelis, FDA has requested mature overall survival data from an ongoing pivotal trial. For Doxil, it is likely another trial will be necessary.
Surrogate Endpoints Don't Convince ODAC: Panel Votes No On Two Centocor/Ortho Biotech Drugs
ODAC votes 14-1 against Yondelis in combination with Doxil for ovarian cancer, and 13-0 against Doxil in combination with docetaxel for metastatic breast cancer.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.