Genentech update 9/24/11 TDM1 study results!!

[chrisy]

Pretty awesome results - TDM1 vs. Herceptin + Taxol!

Genentech's Investigational Medicine T-DM1 Showed Improvement in Progression-Free Survival Compared to Standard of Care in HER2-Positive Metastatic Breast Cancer

The results showed that people who received trastuzumab emtansine experienced a 41 percent reduction in the risk of their disease worsening or death (progression-free survival, PFS) and lived a median of five months longer without their disease worsening (HR=0.59, median PFS 14.2 months vs. 9.2 months). In addition, people who received trastuzumab emtansine experienced fewer common and severe adverse events compared to those who received Herceptin plus chemotherapy, with the rate of Grade 3 or higher adverse events reduced by nearly half (46.4 percent vs. 89.4 percent).

link to the full press release below:

http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13607

[ElaineM]

This is great news !!!!!!!!! Fantastic !!!!!!!! It looks like T DM1 will have a chance with the FDA.
This is especially good news for us in Hawaii after what I heard yesterday. The senior oncologist told me yesterday that he applied for the phase 3 T DM1 Theresa trial for people who have had treatment for her2 breast cancer. He is already running the Marianne trial for people who have not had prior treatment.
He is also convinced T DM1 works !!!!!!

[kykeon22]

What a wonderful news,
TDM1 is truly a miracle drug, it surclassed herceptin which was considered itsself a miracle drug.

This is fantastic, let's hope the the Delay Administration will approve it now and here, no more excuse.

[NEDenise]

Great news!!
So much to be thankful for on this beautiful Sunday morning!!
I f anybody didn't sign the FDA TDM1 petition yet...now would be a good time!
God Bless all of you!
Denise

[schoonder]

Dr. Hurvitz' EMCC t-dm1 presentation:

http://www.ecancermedicalscience.com/tv/?play=1087&cid=0&scid=0&q=

[NEDenise]

Schoonder,
Excellent video clip...easy for a layperson, like me, to understand. Thanks so much for posting it!
Denise

[hutchibk]

Yay! I know it was a fantastic 3 year run for you Chris, and so far so good for me.... I love the positive results!

[Jean]

Hutch and Chrisy,
How much longer before TDM1 is passed ?
Also - will it now be the new standard of care for all
(early stage & advanced)?

The news sure is fantastic.
Jean

[hutchibk]

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 late 2012/early 2013 with additional (Phase III opening quickly in coming months) 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.