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

SunDiego · 08-27-2010, 10:37 AM

This makes me sick.

http://www.google.com/hostednews/ap/...fBFFwD9HRUKQG0

Here is the key sentence in the release: "In its review of the BLA, the FDA stated 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."

In other words, Genentech made a mistake in which clinical trials it chose to do. The current study can't serve as the basis for approval. The company says it "believes firmly" in T-DM1, and that it plans to file for approval in mid-2012 based on as-yet-uncompleted studies.

Essentially this delays by at least TWO YEARS the FDA approval of TDM-1. What was Immunogen thinking?! This doesn't change the trials, but certainly a major setback for those (like my wife) who was hoping access it outside of a trial.

08-27-2010, 10:37 AM	#4
SunDiego Senior Member Join Date: Jul 2010 Posts: 34	Re: Genentech receives FDA Refuse to File Letter for T-DM1 This makes me sick. http://www.google.com/hostednews/ap/...fBFFwD9HRUKQG0 Here is the key sentence in the release: "In its review of the BLA, the FDA stated 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." In other words, Genentech made a mistake in which clinical trials it chose to do. The current study can't serve as the basis for approval. The company says it "believes firmly" in T-DM1, and that it plans to file for approval in mid-2012 based on as-yet-uncompleted studies. Essentially this delays by at least TWO YEARS the FDA approval of TDM-1. What was Immunogen thinking?! This doesn't change the trials, but certainly a major setback for those (like my wife) who was hoping access it outside of a trial.