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J&J's Yondelis delayed by US FDA request for survival data

This article was originally published in Scrip

Executive Summary

The US FDA has requested overall survival data and additional clinical pharmacology studies before it will approve Centocor Ortho Biotech's (Johnson & Johnson) Yondelis (trabectedin) for relapsed ovarian cancer. The request is likely to delay trabectedin's approval by at least two years, which is the time expected for final survival data to accrue.






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