!!! Pertuzumab may be approved by FDA as early as Friday !!!!

[Lani]

Pertuzumab is a monoclonal antibody (like herceptin), but binds to a different area on the her 2 receptor. Wonderful results were reported in San Antonio in a trial, one arm of which involved NO chemotherapy, just targeted drugs.

Hopefully, options for her2+ breast cancer patients will just keep on increasing.

People at the Genentech booth at ASCO were hoping TDM-1 might be approved by very early 2013

^^^^^^^

From Reuters Health Information


U.S. on Track to Approve More Cancer Drugs in 2012

By Deena Beasley

CHICAGO (Reuters) Jun 04 - Cancer drug applications at the U.S. Food and Drug Administration (FDA) are rising, with 20 submissions expected this year, as a better understanding of the molecular makeup of cancer leads to new treatments.

Some of the novel techniques that are proving to be successful include targeting specific gene mutations in tumors and harnessing the body's own immune system to seek out and destroy cancer cells.

"There are a large number of drugs being developed in oncology," said Dr. Richard Pazdur, head of the FDA's office of oncology products. "There is greater understanding of some of the disease processes."

Last year, 10 out of 30 new drugs approved by the FDA were for treatment of cancer.

"This year we expect over 20 oncology applications will be filed," Dr. Pazdur said in an interview at a meeting of the American Society of Clinical Oncology in Chicago.

In terms of approvals, he said some will have decision deadlines that fall into next year or could take longer than expected to review due to issues such as manufacturing, while some may not be approved at all.

So far this year, cancer drugs approved by the FDA include Roche's Erivedge (vismodegib) for basal cell carcinoma; Pfizer's Inlyta (axitinib) for kidney cancer; and GlaxoSmithKline's Votrient (pazopanib) for soft tissue sarcoma.

The agency is slated to decide by Friday on Roche's application for pertuzumab, designed for use in the 25% or so of breast cancer patients whose tumors generate HER-2.

Over the past year, the FDA has cleared several cancer drugs ahead of its legislated deadline.

"It is much easier to approve drugs that have greater efficacy," Dr. Pazdur said. "Our staff is interested getting the drugs out earlier ... it has to be (a) drug that we really think is important."

Oncology drugs are unique in that the regulatory emphasis is on effectiveness rather than safety because patients are often so gravely ill.

"In oncology, the greatest difficulty has been the efficacy issue," Pazdur said. "We are starting to see new drugs with important survival advantages."

That does not mean, however, that every cancer drug to go before the FDA is a slam-dunk if a clinical trial demonstrates a statistically significant benefit for patients.

The issue is particularly sensitive for drug trials designed to show an improvement in progression-free survival (PFS). Cancer drug trials with PFS as their goal are usually much shorter than studies looking at the rate of overall survival for patients treated with an experimental drug.

"It isn't just statistical significance. That gets you in the door," Dr. Pazdur said. "You could overpower the trial -- and we have seen it -- to have a trivial improvement in PFS."

The FDA last year revoked its conditional approval of Roche's Avastin (bevacizumab) as a treatment for breast cancer because, although there was evidence that it slowed progression of the disease, there was no data conclusive showing that it extended the lives of breast cancer patients. The drug is still approved for glioblastoma, colorectal, lung and kidney cancers.

Dr. Pazdur said the FDA is chiefly focused on the magnitude of improvement demonstrated in a clinical trial. "There is a big difference between a 10% improvement in PFS and a 60% improvement," he said.

He also said there is now more emphasis at the FDA on meeting with drug developers earlier and more frequently. "When we are seeing drugs with a high degree of efficacy -- so-called 'breakthrough' drugs -- it requires a different interaction with the companies," Dr. Pazdur said. "We may change the registration strategy or the size of the trial."

[DeenaH]

Finally! I'm just hoping insurance companies will approve it without chemo.

[Becky]

Everyday we are a little bit closer!

[Ellie F]

Hopefully once you girls get it then Europe will follow soon!

Ellie

[ElaineM]

Keeping my fingers crossed that Pertuzamab will be approved by June 8th !!!!!!!!!!!!!!!!

[KDR]

The action date is 8 June. Then, it'll only take five days to get to patients.

I wish that whoever needs it, gets it.

Karen

[Kellennea]

This is WONDERFUL news!!

[kykeon22]

My mother's onco today told us that he has applied for pertuzumab and he is about to get it.

great news XD

[jml]

I'm holding my breath!!!!

Keep the Faith~

Jml

[Rolepaul]

The Her+ sisters and their family members need to put in a word to someone in the government. Let me see if I can find whose office we need to have the bus show up (or who needs to see their email inbox get filled up.) Lani could help with finding the target as well.

[Rolepaul]

Lani,

I hope you ran into my two oncologists up there, as well as my Genentech development friends. I wanted to go, but wife time was more important.

Private mail me if you want.

[KDR]

I wrote to Ms. Hamburg yesterday regarding T-DM1. It was a simple notation to her of who I am, what I suffer from, what I think should be done, and why MY government is not giving out drugs to save its citizens. I asked her to "do the right thing," "imagine me as her daughter," and asked for a response as to why the government thinks it's just fine to feed us pink slime but won't give us drugs we need to live.
It was short, not deep, but to the point. Phil posted email addresses yesterday and I took advantage.
Karen
PS Imagine the money that Medicare would save if the FDA worked in unison with drug companies for a cure? A bailout in itself.

[yanyan]

I hope it gets approved this Friday !!! Was just thinking of this today and wondering how the young mother who had to fight hard to get Pertuzumab is doing. God bless her that she is doing well with the new drug and all young mothers who are fighting this diseases for their little ones!

[Sheila]

I am hoping this drug will be available soon.....I think I am going to need it sooner rather than later as Taxotere is not performing like we thought it would?????.....

[KDR]

Sheila,
Turning to you...what's happening with Taxotere? Have you mentioned this before? Hang in there, you are THE epitome of a Cancer Fighter. You amaze me.
Karen

[Sheila]

Karen..even though I have only had 2 treatments of Taxotere, the new area on my neck has grown, and I now have a reddened area like a triangle at the top of my reconstructed breast going up to my shoulder....I asked the Dr about it last time (last Tuesday) and she said it is the breast cancer.it follows the pattern of the upper part of my bra and where the strap is, but since it is on the breast cancer side, she feels it is the cancer. trying to remain hopeful, but feeling somewhat discouraged...and now bald again! Hoping it kicks in soon...

[KDR]

I just want to hug you, Sheila. I need you to kickstart. You can't give in. You'll find the way out of this, like always. I know you need a break right now, so don't cave to this.

Brighter days ahead,
Karen

[NEDenise]

Sheila,
You've been so strong for such a long time...and you certainly deserve a break...just hold on a little longer...Pertuzamab might be your silver bullet!
I hope it gives you a little comfort to remember that I (and many other sisters) are lifting you in prayer every day during your latest struggle. You are so important to all of us here.

Sending love and a giant hug through cyberspace.
Keep your chin up...my gut tells me help is on the way!
Denise

[Bunty]

I second Denise's post Sheila! Fingers crossed that very soon you will be one of the first of our crew to take Pertuzumab, and that we'll be reading your posts for many years to come!

I hope they approve it in Australia soon too.....

Cheers Marie

[dawny]

Bunty, it is on trial in Geelong at the moment, but only for early stagers. I have heard talk of it being available to all in late 2013, early 2014. So we still have to wait.

Best wishes to you Sheila!

Dawn

[phil]

I hope its true. Seems like approval for pertuzumab is a no-brainer. Dr. Pazdur will probably crow about it, as His FDA is feeling the heat from this weeks debut of t dm-1, the historic " smart bomb " that His Agency bungled back in 2010. He will talk, talk, talk up pert , and it is very good. He wont talk about rejecting t dm-1 ... 38 %... Embarassing. Deadly for many of us. We wont let him sweep it under the rug... AP says it " just missed the rigid cutoff for immediate approval ", couldnt bend it ? Does anyone think This FDA is capable of un-biased tx of t dm-1 ?

[Lani]

Sheila,
Am still exhausted from the conference and 7 ADDITIONAL hours of jetlag since the conference (yes, I am the scarlet pimpernel!) but could you have radiation recall dermatitis?

Google it, review your drugs and your radiation field and let me know if am just in some sleep-deprived, jet-lag induced confusion or perhaps barking up the right alley.

I have only read about it, but wouldn't it be nice if it were something other than cancer.

I read a number of scary things about your proposed radiation treatment way back when and tried to post some of it without alarming you prior to your decision on your brachial plexus treatment...some of these side effects happen late and some may perhaps be amenable to trreatment eg perhaps trental for postradiation fibrosis.

Since you are now in the realm of rare problems, perhaps it would be wise to review some of the literature. I doubt many individual oncologists or radiation oncologists even in cancer centers have a lot of experience with those with brachial plexus involvement so it might be wise to compile all of it and look for trends. You should not have trouble with the terminology I suspect as I recall you were trained as a nurse and researched and spoke up admirably about the price of herceptin.

Try to separate yourself from what you are reading in the literature-- my usual suggestion is to substitute the words chcocolate, marshmallows and whipped cream for words you don't like to read such as metastasis, overall survival, progression free survival and try to slog through the literature.

Unfortunately,they still don't really know for sure HOW radiation works against breast cancer and what makes different people react differently to radiation therapy (no doubt it is largely genetic).

If I am not just stuporous and imagining things and it might be radiation recall dermatitis, at least the problem would not be the cancer itself. Even if I am totally whacked out and delusional it couldn't hurt to review the literature on radiation to this area and the reaction to it, results from it to try to understand what might be going on.

Best of luck!

[KristinSchwick]

Love you Shelia- hang in there. Thinking of you!

Also just wondering what the FDA approval for pertuzumab will mean for most of us? Will it be for metastatic breast cancer patients? Will it be for people who have failed other her-2 therapies and what sort of other chemo agents will it be given with? And anyone know how long it could take for insurance agencies to pay for it?
Thanks

[Lauriesh]

It's going to be approved as a first line treatment for mets (those newly diagnosed with mets) in combination with Herceptin and taxotere.

Of course, a dr can prescribe it off label, but then the question will be, will the ins pay for it.

I had to fight my ins. to pay for tykerb, because I wasn't taking it with Xeloda. It will be interesting if ins. will deny covering this drug, if used outside of what it was approved for.

Laurie

[KDR]

Sheila, would a tiny specimen via biopsy help?

Phil, Go, Phil! In horseland, we used to use a twitch around the upper lip to stabilize an out of control animal...fits here, doesn't it? Sick of the stalling and cover-ups...do we have any adults in the FDA house?

Karen

[Mary Anne in TX]

Cyber hugs and hope to Sheila Girl! You gave your hair, now taxotere needs to do it's job for you! ma

[msmanuf]

Wow !! What exciting news. I haven't started Herpecin yet, called my onco to see if I would be eligible if it is approved tomorrow. Praying for everyone. I am very early stage so, hopefully I will be given the gift of Pertuzumab. I am sitting on pins and needles..like everyone else is.

Mary Jo

[chrisy]

My concern also, about if it will be covered by insurance beyond the strict label approval.

[Rolepaul]

Talk to the VP of patient affairs at your insurance company. This should be paid for if the government approves it. I will try to get to Anthem Blue Cross Blue shield to find ou.

[msmanuf]

Will this be a first or second line med?

Thanks,

Mary Jo

[msmanuf]

Hi, not sure what I am, but first line with mets does that mean it has moved somewhere else in the body? Mine hasn't moved anywhere else. Suppose to start tch tomorrow.

[msmanuf]

wooo hoooo congrats

Mary Jo

[Lani]

pertuzumab will probably not be useful as monotherapy(and thus is not a substitute for herceptin), but wil combined with herceptin (where it will be especially effective against the her2-her3 heterodimers) and even also lapatinib. It may/will probably end up being somewhat more effective when used with a taxane (although I hope not, as it would be lovely to have a purely targeted therapy only combination). Kent Osbourne and Racheal Schiff have opined that it might require an AI in the combo in ER+ her2+ cases.

Approval for a drug in the metastatic setting usually comes long before approval in the adjuvant setting as 80-90++% of those who are stage IV have historically succumbed within 10 years, whereas most of those in the earlier stages 90% or more never have a recurrence. When so many are expected to do just fine, they must weigh the safety issues in the cost/risk/benefit analysis. As an example I believe herceptin was approved for metastatic her2+ bc in the late 1990s but not for early breast cancer until late 2006 or sol

The good news was pertuzumab did not seem to be responsible for any more cardiotoxicity when added to herceptin compared to herceptin alone.

[Lani]

Sheila--

http://www.cancertreatmentreviews.com/article/S0305-7372(05)00126-X/abstract

Summary
Introduction
Radiation recall is an inflammatory skin reaction at a previously irradiated field subsequent to the administration of a variety of pharmacologic agents. Although skin has been the major site of radiation recall toxicity, instances involving other organ have been reported.

Materials and methods
Data for this review were identified by searches of Medline and Cancerlit. The search terms “radiation”, “recall”, and “toxicity” were used. References identified from within retrieved articles were also used. There was no limitation on year of publication and no abstract forms were included. Only articles published in English were taken into consideration.

Results
Idiosyncratic drug hypersensitivity phenomenon is a recent hypothesis which correlates best with the available facts at this moment. The phenomenon may occur days to years after radiotherapy has been completed. The majority of the drugs commonly used in cancer therapy have been involved in the radiation recall phenomenon. A mixed non-specific inflammatory infiltrate seems to be the common histopathologic criteria in previous published reports. Universally, corticosteroids or the use of non-steroidal anti-inflammatory agents, in conjunction with withdrawal of the offending agent, produce prompt improvement.

Conclusion
We propose to collect all future radiation recall phenomenon in a Rare Cancer Network database in order to augment our understanding of this rare reaction.

[Sheila]

Lani
Thank you for the info...I spent a good part of the day reading up on the radiation recall dermatitis...it looks very similar to what I have on the breast, and I retried on my mask today, and it appears that area was in the radiation field. I have an appointment Monday with the rad onc Dr in Chicago...I will be going with info in hand...hope I get an answer. Thank you for the valuable info...I kept wondering if it was from the radiation.....I will let you know.