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

 
• By Sue Sutter

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.

FDA’s Oncologic Drugs Advisory Committee was not entirely sold on the use of pathological complete response (pCR) as the basis for accelerated approval in neoadjuvant breast cancer, but in the case of Genentech Inc.’s Perjeta (pertuzumab), it was willing to take a chance on the unvalidated surrogate endpoint.

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