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

 
• By Emily Hayes

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 guidance on the accelerated approval pathway for neoadjuvant breast cancer likely will include an assessment of the failed ALTTO study of GlaxoSmithKline PLC’s Tykerb, but FDA does not plan to alter its course on speeding clearance of new drugs that show a robust effect early in high-risk women.

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