FDA Decision Re Perjeta

[KDR]

http://www.everydayhealth.com/breast...6pLid%3D376534

[Lani]

It is not yet the FDA decision, it is the decision of an advisory panel ...the FDA may rule otherwise, but usually goes along.

I posted this twice previously and noone responded to either your post or my post.

Not sure why. It is groundbreaking as never before has pCR being taken into account in giving approval (and early at that)

[KDR]

Multiple postings are not unusual. I'm expecting "big" things; I've become more expectant than I previously was.

Let's go, chemists. Then, get on it, FDA. Now.


Karen

[vballmom]

I am always reading, but try to respond when I have some value to add. I appreciate these informative posts more than I can possibly say here.

[Redwolf8812]

I also appreciate the informative posts, although I don't always respond. This is great news, but I wish it would be approved for us Stage 4 patients who have already had "first-line" treatment. I was denied perjeta for this reason.

['lizbeth]

Penny,

The standard of care guidelines are starting to become more and more complex. You can have this treatment as first line, that treatment as 2nd line. I'm disappointed to that you couldn't receive it. I wish approvals could be more broad.

@Lani, after 4300 posts we just take you for granted.
The Perjeta for neoadjuvant treatment is big news and shows an enormous shift in standards (pCR). We share your enthusiasm and note that you were the first to scoop the story.

[Lauriesh]

Penny, have you appealed the denial?
When I wanted to add in tykerb without xeloda, my ins denied it, but on appeal they covered it.
I am starting perjeta soon, and it is not my first line treatment and ins is covering it.

Laurie

[Redwolf8812]

Yes, an appeal was done, and denied. And we make just over the $100,000 threshold for compassionate care.

[KDR]

I have heard that if you go to a smaller clinic you can get Perjeta. I don't know the reasons why exactly (maybe someone does), but that's what I was told at my "big" institution.

Karen

[Lani]

I was not trying to take credit or "scoop"--I commented because of my disappointment when I saw the title of the thread "FDA decision re perjecta" When I spotted it I thought somehow the FDA agency rather than the advisory committe had made a decision and clicked on it hoping to read the agency had made a decision. I was disappointed to find the title of the thread had misled me.

Let's keep hoping for a positive agency review pronto!

[Lani]

Looking back I even added a second link in hopes of getting someone to notice the post as I was quite enthusiastic about both what it meant for her2+ patients AND what it meant regarding possible earlier approval of treatments for ALL cancer patients ie, I hoped by reposting to move it back up to people's attention.

Noone seemed excited enough to post and then , voila, the post about FDA decision .... falsely raised my hope further.

The decision will probably come in the next 5-6 weeks...then the next step....seeing if insurance companies will pay for multiple expensive targeted therapies for early stage bc patients. Let's hope!!

[KDR]

It was a panel for FDA's decision to back "wider use" of Perjeta. Still good news. Not the best, but good.
Moderator, if the collective sees fit to change the title, please do.

Karen

[Lauriesh]

I guess I am with redwolf. Why are they considering it for early stage when they have not even approved it for all stage 4 patients.
It feels like a slap in the face for those who are stage 4.

Laurie

['lizbeth]

The title could have been clearer, but if one reads the post they will realize it is the advisory committee, not the FDA gave Perjeta the thumbs up.

40 days to Halloween, a lot could happen in 40 days - world wide floods, who knows? So excited.

@Lani, you did ask why they didn't respond to your 2 prior posts. We know how you scientific minded individuals love recognition. And I am taking the "first to scoop status back" - I actually posted about this in August and forgot (chemo brain/senior moment?)

This is an enormous shift in medicine and drug approvals if it gets the green light. We are very happy that you are involved enough in keeping up with the latest - to bring it to our attention. "Groundbreaking" - I would totally agree.

I am very excited about the change to pCR, instead of DFS or OS. It gets the industry out of the mindset of sacrificing patients' lives to prove that a medicine works in order to get the FDA stamp of approval.

I see that the stage IVs are struggling with the approval for early stage when not all of them are eligible. I can tell you that I look at Tykerb and Kadcyla and realize that they are not available to early stagers without a clinical trial. And Perjeta is not available to all early stage either. If the tumor size is below 2cm, or if the patient has done surgery first - they will likely not qualify.

Be generous of spirit - the Herceptin, Perjeta and Taxotere combination will likely prevent many from progressing to stage IV, and if carboplatin is added (like the Tryphaena study) another 20 women per 100 could reach pCR.

The more patients this drug is approved for, the more likely it will be approved for other uses, like all stage IV patients.

I eagerly await the news from the FDA, like the rest of you.

[Lani]

Lots of suppositions about "science-minded" people--- My original field was in the "fine arts" and even then you would think THOSE people wanted recognition
but I didn't. Don't even like my photograph being taken.

Prefer to be the "Scarlet Pimpernel"--elusive, anonymous

[phil]

lani, I know i responded to one of your posts on perjeta. and i too greatly appreciate your research and sharing of info.
This FDAs' ( post 2009) mis - handling of t dm-1 was the major screw -up that only highlighted the slowness of the System . With perjeta , we are back to " business as usual ", yrs and yrs of slow , piece-meal appr. while stage ivs die !
way back in june, 2012, this FDA gave appr. for perjeta for pts , " who have NOT recieved ANY anti-her2 therapy " , first -line. shutting out the stage ivs who sacrificed in the phase I trials of all these drugs, to get it to any further testing. now we see a panel recommending it for neo- adj. and still Stage IV's are shut out ! its infuriating . even the article sub title you cite infuriates me - the superficial media coverage , " Perjeta, which seems to shrink her2 + bc tumors, , might gain " QUICK " FDA approval "... and on that FDA ODAC panel , " our " only spokespeople are bc action , who are pro-FDA biased at this point , a group that actually wrote the FDA asking them to deny early appr. to t dm-1 ! They do not represent Stage IV !

[Lauriesh]

I agree with Phil. There are stage 4 women who could benefit today from perjeta and who can't wait years for approval
It is hard, lizbeth to be " generous of spirit" when you are stage 4 and you see other women with young children who are dying because they don't have access to drugs that are out there but we're approved for such a limited use, they can't get them.
There is a difference between early stage having access to drugs and stage 4. We are terminal. We know what we will die of, and need every drug that is available now to keep us alive.

Laurie

['lizbeth]

Laurie,

Well I didn't want everyone to be quite that generous, as in not receiving Perjeta for years. But this potential FDA approval could save many early stagers from progressing to stage IV, and as Lani pointed out - it is quite novel, a paradigm shift, to base an approval on pCR. Some mother who is diagnosed in 3 months or 6 months might not needlessly suffer because of this approval. With this blessing of receiving Perjeta early she could become another one of the long time survivors who never had a recurrence.


I've been mulling on this issue. I thought Herceptin was approved for all stage IV, and then years later the earlier stages.

Now I see this piecemeal approval process where you can get this drug if you are first line, that one second line and so on . . .
and again the neoadjuvant Perjeta seems quite limited, only 2cm or larger. So if you are lucky enough to have early detection you are not lucky enough to receive Perjeta?

I was looking at the Perjeta trials for stage IV to share. I found a promising one internationally, but for the US - am I missing something?

And to be honest, I don't understand the compassionate use policies. It seems to me that I see so many postings that yet another stage IV cancer patient was denied a drug that is in clinical study. Why? Why do we as a society allow people to die when a possible treatment exist and a person is willing to try it? Cost, legalites, risk of delay treatment approval?

It all sucks right now, especially with Mandamoo struggling.

But if Perjeta gets fast-tracked based on pCR - it could really change the fast-track approval process. Could you imagine a stage IV trial based on pCR and not OS? This could be the start of what you wish for, faster FDA approvals of medicine for those who are in critical need.

['lizbeth]

Fine arts Lani? I would have never guessed that. The privacy part, yes.