Health News

The Food and Drug Administration (FDA) has issued a Refuse to File letter for accelerated approval of Roche’s trastuzumab-DM1 (T-DM1) Biologics License Application, which was submitted in July 2010. Roche had requested accelerated approval for T-DM1 based on the results of a single-arm Phase II study. In that study one third of advanced HER2 positive breast cancer tumors shrank…

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Filed under: Pharmacy News
Tags: Breast Cancer, cancer, Drug, Pharmacy, Tumor

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