News
08-27-2010, 10:10 AM
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...
More... (http://mnt.to/f/3HZ5)
More... (http://mnt.to/f/3HZ5)