Genentech Receives Refuse To File Letter From FDA For T-DM1

[News]

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, announced that Genentech, a member of the Roche Group, 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...

More... (http://mnt.to/f/3J5F)

[schoonder]

Hopefully for people in need of this potentially effective and well tolerated drug there will be ways of getting around this what looks like at least a 2 year approval setback.
Linked article gives some insight and background on what might have brought on this FDA ruling.

http://seekingalpha.com/article/223275-immunogen-what-really-happened-with-t-dm1s-filing?source=yahoo