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Neoadjuvant Surrogate Endpoint Is Tough Sell, But FDA Panel Says Perjeta Worth A Chance

Executive Summary

Despite concerns about accelerated approval on the basis of pathological complete response, which has not yet been correlated with improvements in longer-term outcomes, FDA panelists say the large body of efficacy and safety data supporting Genentech’s pertuzumab makes it worth the regulatory risk.

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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.

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

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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