Plea To FDA: Set Realistic Bar For New Breast Cancer Trial Endpoint
Commenting on FDA’s draft guidance for accelerated approval using a relatively new surrogate marker of pathologic complete response, Roche/Genentech is wary that FDA may expect too high a bar for results. BIO asks FDA to consider safety when evaluating “magnitude of benefit.”
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FDA’s Early Breast Cancer pCR Final Guidance Stresses One Trial
Final guidance from FDA on accelerated approval pathway based on pathological complete response in neoadjuvant breast cancer clarifies that one large trial is the “default” for most applications.
Breast Cancer Experts Suggest Minimum Benefit For New pCR Surrogate
Pathologic complete response in neoadjuvant breast cancer trials is reasonably likely to result in better long-term outcomes, but how big the pCR improvement needs to be is a matter of guesswork.
Genentech Resubmits T-DM1 To FDA, This Time With An Overall Survival Benefit
The antibody drug conjugate showed a significant overall survival benefit in HER2-positive metastatic breast cancer in the EMILIA trial, the company announced.