Breast Cancer Study Primary Endpoint Should Be Time To Progression - Cmte.
Time to progression should replace response rate as the primary endpoint in clinical trials for first-line hormonal drugs that treat metastatic breast cancer, FDA's Oncologic Drugs Advisory Committee said Sept. 10.
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FDA should not replace AstraZeneca's Nolvadex (tamoxifen) with Novartis' Femara (letrozole) as the standard comparator for first-line hormonal drugs for the treatment of metastatic breast cancer, FDA's Oncologic Advisory Drugs Committee agreed Sept. 10.
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