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ODAC Says Toxicity Trumps Meager PFS And TTP Benefit for Yondelis, Doxil

Executive Summary

Changing endpoints midway through the clinical trials for the two Centocor/Ortho Biotech oncology drugs reviewed by FDA's Oncologic Drugs Advisory Committee July 15 did not help their regulatory prospects - but in the end it was the poor efficacy and unacceptable toxicity that doomed both Yondelis and Doxil

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