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Revised pCR Guidance Likely To Include Failed ALTTO Trial, FDA Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Oncology office director Pazdur says whole data package supporting accelerated approval in neoadjuvant breast cancer of Roche’s Perjeta was far stronger than the data for GSK’s Tykerb, which just failed in ALTTO. FDA is standing by use of pCR as a surrogate endpoint but says only a select group of drugs will qualify.


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