HER2 Support Group Forums - View Single Post - Genentech receives FDA Refuse to File Letter for T-DM1

sarah · 08-27-2010, 11:05 AM

This is terrible and the fact that they say "the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population."
what has non-HER2 bc got to do with HER2 positive cancer????!!!
It's outrageous and a letter writing campaign to representatives in Congress is in order. I'm sure Genetech will be helpful in suggesting the best course of action.
sarah

08-27-2010, 11:05 AM	#5
sarah Senior Member Join Date: Sep 2005 Location: france Posts: 1,648	Re: Genentech receives FDA Refuse to File Letter for T-DM1 This is terrible and the fact that they say "the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population." what has non-HER2 bc got to do with HER2 positive cancer????!!! It's outrageous and a letter writing campaign to representatives in Congress is in order. I'm sure Genetech will be helpful in suggesting the best course of action. sarah __________________