Re: Pertuzumab: Today's The Day
 

Karen, you're right. My newly retired local oncologist threw that cold water on my enthusiasm about pertuzumab when I saw him a few weeks ago. But I think that if the data is strong, people will be able to get access.

Re: Pertuzumab: Today's The Day
 

The insurance will be the key. Pertuzumab like all brand new drugs are, will be highly priced so Roche can recoup their investment. Insurance co's are not in business to help patients--they want to make money so I'm betting they will closely scrutinize claims for Pert. in effect, unintentionally policing for the FDA.

If the FDA had approved this 2yrs ago when it was reviewed, which was before my dx, I and others would have benefitted. But they didn't, so basically they have decided our lives are not worth it---not then, not now.

I'm very, very letdown about this but I see my onc Monday and will discuss if Pert. will be an option for me if God forbid, my mets do not respond to Abraxane.

Re: Pertuzumab: Today's The Day
 

So this IS the "conditional " approval that was rumored to be coming ? Un-believable ! as we see it help late stage folks like Darlene Gant !
I was looking for it on Fri, couldnt find it , nor in newspaper Sat. Turns out FDA released new of approval at 8:30 Fri. night . I thought that was wierd. reminded me of how they waited until Fri before Thanskgiving to release news that they were revoking Avastin. I had expected FDA to crow about pert., to distract from thier bungling of t dm-1, but now it appears that they are as sneaky about a partial approval of pert as they were w/ revoking avstin. Hmm, and maybe still punishing Gen., keeping it out of news . Cmon, a press release at 8 :30 on a Fri ? Its a dirty business, backroom connections . When Lorraine and I were at Avastin hearings , on abreak we saw atable full of pastries, juice , coffee . Silly us , we thought the FDA was putting that out for Survivors, NOT !. An embarassed woman asked us if we were w/ " Re-Li Associates ". Said the spread was for them. I asked who they were , " Not at liberty to disclose " In this System you Survivors have NO SAY ! We deserve a place at the table ! Its really about US ! I want to look into this FAST ACT before Congress, HR 4132, to overhaul FDA acc. approval. I hear its stagnating , lacking sponsors. Ask your Congr. to look into it. Add some real Survivor advocacy/ in-put. really change this Crooked System !
Come Demonstrate w/ us on June 19th at BIO in Boston ! Senior FDA will be there , running a " Town Hall " on " speeding up drug approvals ", gag me !!

Re: Pertuzumab: Today's The Day
 

I am happy for the unfortunate women or men who may turn stage 4 but why such a restrictive announcement?
Why exclude already metastatic patients? It sounds like a trial not a release. Can someone explain? Is it the production problem, the lobbying from insurance companies, a FDA trick? Michka

Re: Pertuzumab: Today's The Day
 

I hear that gen. says they have enough for anticipated present demand.
I suspect This FDA - Dr. Pazdur and his top aides in the Oncology Drug Product Review Division show no signs of real concern for Stage Iv pts. They are continuing thier quest for Testing over saving Lives.
I believe that they purposely released the news late on a Fri. night. Some wierd attitude towards Gen., and /or accelerated approval as practiced in past. Wierd , because complete pert approval should be a no- brainer, w/ a minimal s/e profile , based on herc. hx. I told you about my experience at Avastin hearings, that " Re-Li" Associates little " feast " was down a back hall, next to aroom they had set a side by FDA . To me , it tells who has The Power in DC , and It isnt You ! Speak Up ! Our reps should be grilling This post 2008 FDA about Pert right now ! Write them !

Re: Pertuzumab: Today's The Day
 

Next mission: Occupy The FDA.

It was weird that the approval was announced early evening, but I'm new to this, so I don't know what to expect. But it kind of sounds like getting the anticipated school packet with new teacher's name on the day before school starts so there's no time for parents to make changes.

Anyway, the approval was given based on the study group, and when "efficacy" is shown in others, they'll follow suit. Now you know why, on Facebook, I indicate "Lost All Faith In Politics" when asked to state my persuasion.

Karen

Re: Pertuzumab: Today's The Day
 

Thank you ladies and gents who gave the "heads-up," starting with Chrissy.

After my initial enthusiasm, the first thing I thought about was insurance company denial based on a first-line treatment criterion. This is a major issue. Of course, under their discretion, doctors can prescribe pertuzumab (or anything else), but the issue is whether insurance companies will cover it. Also, private insurers aside, will Medicare cover it?

The FDA approved pertuzumab for exactly what is was tested for. That combination showed efficacy. Not any other combination or eligibility criteria. However, in our real world, that creates a problem for us.

I have a plan to work on that problem.

Joan

Re: Pertuzumab: Today's The Day
 

Joan,
What do you propose?

Genentech is working on this, too, I am sure they want nothing more than to have this available to everyone, hence their program, Access Solutions, that will liaise between onocologist and insurance company.

Karen

Re: Pertuzumab: Today's The Day
 

I didnt get the whole story, but I was told by an oncologist friend (not my onc) that there was a gag order regarding the approval of pertuzumab. Not sure on who (media maybe?). Supposedly they are holding back on pertuzumab because genentech's big money maker T-DM1 will be approved in sept. They are both made by gen, but they think they will make more on T-DM1. As far as which is better, he said there has never been a drug as effective as pertuzumab....ever. And that includes herceptin! I will be fighting tooth and nail to get this drug. In combo with herceptin and tykerb. I hate that this is more about money than saving lives...