EMILIA Results Are In , Good News !!

[phil]

Genentech issued a Press release yesterday , announcing that EMILIA's results show that Herceptin T DM-1 significantly out -performs Tykerb/ Xeloda in terms of PFS, OS pending. We Survivors/ Caregivers also know it will ven more significantly out-perform Tykerb/ Xel. in terms of QOL. We are not surprised, nor are Research Oncologists . The only ones " surprised " are Dr. Pazdur and his T DM-1 " advisors " at This FDA !
At the end of the Press Release , Gen. mentions that they have THIRTY " conjugates " in the pipeline ! Conjugates are genetic drugs with chemo directly attached . T DM-1 is the only one out there right now, but imagine if even a few others come out over the next few yrs !
The down-side is that Gen.'s press release says it will file an application with This FDA " later this yr. " ( Summer ?) . Then This FDA typically will take 6 months to make a decision, which brings us to 2013 !! And Dr. Pazdur , who has been obstinately blocking the drug for 19 months, will make an " im-partial ", " rational " decision ? We think not ! So, that is why we have been callling for HHS to Investigate This FDA , and will continue to speak out. Sign our HHS Petition at signon.org " FDA Blocks Life Saving Drug ". Pass It On !

[Jackie07]

Thanks, Phil. I think all the red-tapes were caused by what had happened in the Avastin trial/approval saga. Hopefully T-DM1 will be available soon and we all can benefit.

[fullofbeans]

Phil,

thanks for being on the case. Here from the EU maybe we should put pressure on the European medical agency which is our FDA here and pressure on both sides can only help me think. 30 conjugates sound like things could be looking up for less toxic treatment ahead, shame some of us will not make it because of the delays and red tapes.

well done again Phil to be on the case

[Ellie F]

Good news for sure. Wish it would hurry up for sure! Agree with FOB that we should put pressure on EU as well but will have to find out the process for doing this. We need to join with sisters in France and other countries.
Elllie

[schoolteacher]

Yeah! I was a participant in this trial. I took Xeloda and Tykerb for almost 10 months and had progression. I am still on the Tykerb.

Thank you Genentech. Come on FDA.

Amelia

[Ellie F]

Thanks Amelia for taking part.
Without people like you this important research would never happen.
Hugs
Ellie

[Mtngrl]

Yay!! Keep those new treatments coming. . . .

[phil]

gen. will file with both This FDA and the EMA ( FDAs equivalent in Europe ). I am betting that the EMA beats This FDA to full approval.

[chrisy]

phil, I sure won't take that bet from you! But maybe This FDA will finally do the right thing. heaven knows they've had enough time to look at data!

[ElaineM]

I have my fingers crossed for approval too !!!!!!!!

[phil]

3 more sigs needed to reach 7,000 on the Petition to Investigate This FDA !! Keep Up The Pressure !!
signon.org , " FDA Blocks Life Saving Drug "

[KDR]

Phil,
Could you post the link, please? Hope Lorraine is feeling great, and will speak with you soon.
Karen

[phil]

http://www.signon.org/sign/fda-blocks-life-saving.fb1?r_by=1217564

[KDR]

Thanks, Phil. This is the one that circulated earlier, right? I don't want to double sign. PLEASE EVERYONE, just put the above link in your browser and sign this petition, also send it on to your largest bank of friends.
Thank you,
Karen

[phil]

Yes. I was a little off , we need about 90 sigs to get to 7,000.

[tricia keegan]

Thanks Phil and will share on a UK site I moderate as full of beans mentioned to get the word out here and also on my FB!

[Lettik]

I just signed it and passed on to family and friends. Thank you for the link.
Letti