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

Nancy L · 08-27-2010, 04:28 PM

Does anyone know the names of the FDA review committee who made this judgment? I am interested if any are oncologists who are really up on Her2 breast cancer or for that matter, any kind of breast cancer. What we all have is unique and very different from other breast cancers and the FDA needs to understand this. Making us receive every chemo invented for breast cancer before new targeted therapies for Her2 is absolutely crazy and not cost effective either.

I am going to ask Dr. Slamon if the Her2 oncology community is going to protest this decision.

08-27-2010, 04:28 PM	#12
Nancy L Senior Member Join Date: Apr 2009 Location: La Quinta, Ca Posts: 253	Re: Genentech receives FDA Refuse to File Letter for T-DM1 Does anyone know the names of the FDA review committee who made this judgment? I am interested if any are oncologists who are really up on Her2 breast cancer or for that matter, any kind of breast cancer. What we all have is unique and very different from other breast cancers and the FDA needs to understand this. Making us receive every chemo invented for breast cancer before new targeted therapies for Her2 is absolutely crazy and not cost effective either. I am going to ask Dr. Slamon if the Her2 oncology community is going to protest this decision.