Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-
 

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

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Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
 

UGH....I am extremely disappointed. After reading all the good results of this drug on the board, this was the next treatment on my personal list of options.

VERY frustrating to be so close.

I am sure my sentiments are shared by others.

Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
 

Disappointed does not even begin to say it. I'm trying to contact Genentech patient advocacy group as I write this. Here is the Genentech press release

http://www.gene.com/gene/news/press-...etail&id=12927

Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
 

Really terrible news for all her2 positive folks. Chrisy let us know if we can do anything. Is there a petition we can sign?
http://www.reuters.com/article/idUSLDE67Q03620100827

Re: Genentech receives FDA Refuse to File letter for accelerated approval of trastuzu
 

I was shocked when I ran across this article last night. This is unbelieveable! From everything I have been hearing I really believed we would have it OK'd earlier rather then later. There are so many women that need this drug and now.

As Elaine already said...let us know Chrisy if there is something we can do? Where to call, write or picket...I'm there. (OK...the picketing might be over doing it...but I'm just saying.)

Chelee