[hutchibk]

T-DM1 is a 2-in-1 "Trojan Horse" therapy in which Herceptin zeroes in on the cancer cells and delivers a chemotherapy agent that stops cancer cell division. Trastuzumab emtansine (also known as T-DM1) consists of the DM1 cancer cell-killing agent attached to the HER2-binding antibody, trastuzumab. Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate (ADC) that combines intracellular delivery of the potent cytotoxic agent, DM1 (a derivative of maytansine) with the antitumor activity of trastuzumab. While there are several ADCs in Phase III development, T-DM1 is the only one in which the targeting antibody has antitumor properties. T-DM1 is also the only ADC that is directed toward the human EGFR 2 (HER2). Effective therapies are limited in HER2-positive advanced or metastatic breast cancer (MBC), particularly following progression on available HER2-targeted therapies.

Which trial did you try to qualify for? They are getting ready to open Phase III trials any day now, and you might qualify for that... I don't know if you would be guaranteed to get TDM1 or another standard of care, but if you can qualify it would be worth a shot.

They asked the FDA last summer (2010) to fast track it and give it accelerated approval, but the FDA shot it down with (in my opinion) lame reasoning... requiring additional data from further studies. I think they hope to go back to the FDA in 2012 with additional data that will finally get it the approval that it deserves. They need the data from the imminent Phase III trial to make the FDA happy and gain approval.

I am in the TPAS arm of it and it is working really well for me so far...