Pertuzumab: Today's The Day
 

For approval! Keep watch! I did just hear that they have a little wiggle room until next week, however!

Come on, FDA, let it go!

Karen

Re: Pertuzumab: Today's The Day
 

The novel monoclonal antibody pertuzumab, functions by preventing dimerization of HER-2 (the target of Herceptin) with other members of the human epidermal growth factor family: HER-1, HER-3 and HER-4. In doing so, the cross-talk between receptors is abrogated and downstream signaling is squelched. The most interesting aspect of this reflects the downstream pathways it targets. Pertuzumab inhibits signaling at the PI3K pathway, upstream from mTOR. In cell function analysis, this is the truest sense of the word, a breakthough in metabolomics. Much like genomics aims to unravel the structure of the genome, metabolomics focuses on understanding the many small molecule metabolites that result from a cell's metabolic processes.

http://her2support.org/vbulletin/showthread.php?t=54087

The Cancer “Breakthroughs” that Cost Too Much and Do Too Little

Perjeta is not a cure, added to standard treatment with Herceptin. Perjeta gives the average breast cancer patient only about six months more of calm before the disease starts to stir again. Given the limited benefit, the price is startling. A full course of the drug combination will cost $188,000.

Americans spent more than $23 billion last year for cancer drugs, more than we paid for prescriptions to treat anything else. But many oncologists are starting to question what we are getting in return for that bill, whether the war on cancer has become too much of a race to produce the next blockbuster.

http://www.thedailybeast.com/newswee...oo-little.html

Re: Pertuzumab: Today's The Day
 

Fingers x here across the pond! We soooooo love good news and this would certainly be that.
Ellie

Re: Pertuzumab: Today's The Day
 

I know. I know. I have my fingers crossed too.
Pertuzumab is going to help alot of people.

Re: Pertuzumab: Today's The Day
 

Also, Pertuzumab must be given with Herceptin.

Karen

Re: Pertuzumab: Today's The Day
 

Yay!!!! Fingers Crossed!

Re: Pertuzumab: Today's The Day
 

Approved!

FDA Approves Perjeta (Pertuzumab) for People With HER2-Positive Metastatic Breast Cancer


http://www.marketwatch.com/story/fda...cer-2012-06-08

Re: Pertuzumab: Today's The Day
 

Woo hoo! Every weapon helps!!!

Re: Pertuzumab: Today's The Day
 

Yayyyyyyyyyyyyyyyyy! Thank you, Jesus!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Re: Pertuzumab: Today's The Day
 

Reading this is confusing me.

"Perjeta is approved in combination with Herceptin(R) (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease."

Is this approved ONLY for patients who have not previously been treated with Herceptin and/or chemo?

Re: Pertuzumab: Today's The Day
 

"who have not received prior anti-HER2 therapy or chemotherapy"

Yeah..sure hope this is not enforced.

Re: Pertuzumab: Today's The Day
 

Ditto Vicki.

Re: Pertuzumab: Today's The Day
 

It reads to me first it is only for metastic her2 bc; second it is approved as first line treatment for metastic her2 bc. So if you haven't received any therapy for her2 metastic bc you are eligible for this drug combined with Herceptin and docetaxol
So for people whose disease has not progressed to stage 4, this will be the 1st line treatment once the disease progresses to stage 4.

Re: Pertuzumab: Today's The Day
 

"Who hasnt had herceptin if you are her2 positive? "

Good point. Methinks wires are crossed.

Re: Pertuzumab: Today's The Day
 

Me too, in that case nobody would get it. All will become clear soon and I suspect more trials will open to assess its use in other combinations
Ellie

Re: Pertuzumab: Today's The Day
 

Is the FDA only going to approve it for new her2 patients that are initially diagnosed at stage 4 and current her2 patients that become stage 4 but haven't been treated by Herceptin before? These articles are so hard for me to digest.

Re: Pertuzumab: Today's The Day
 

Although I am so happy to see the FDA approval, I have to admit I am sad and disappointed to read that it won't be available for stage 4 people like myself who are already on Herceptin. This just doesn't make any sense to me and makes me sad.

Re: Pertuzumab: Today's The Day
 

As I understand it, your doctor WILL be able to use it at his/her discretion. The "approval" was granted based on the study group.

Karen

Re: Pertuzumab: Today's The Day
 

The approval is for first line metastatic disease. So if you had adjuvant herceptin for early stage disease then later recurred as stage IV, this approval would apply to the first treatment AT STAGE IV.

The issue will be for those who have already had one or more treatments for metastatic disease.

As far as "enforcement", a doctor can generally prescribe an approved drug "off label", meaning for a different indication than the FDA approval. Example, for a patient who has already had one or more treatments in the metastatic setting.

The problem for access will be getting insurance to cover such off label use. That will be the big battle.

Re: Pertuzumab: Today's The Day
 

This approval is a start. Chrisy is right, it will be "off label" for non first-line patients and insurance coverage will depend on the carrier. There is a program in place, through Genentech, called Access Solutions that can contact insurance companies on behalf of the doctor and patient. There are other trials (like mine) for patients who have progressed on first-line treatment, and those studies are current and enrolling, so that is also an option.

Karen

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...