Disturbing news about Iressa

[cathyr]

I am posting this so that anyone who is taking Iressa can check this out for themselves. A report 2 hours ago from Astra Zeneca (mfg. of Iressa) just announced that Iressa has proven to be no more effective than a placebo and may be taken off the American market. The web site to check this out is

http://news.google.com/news?q=iressa&hl ... a=N&tab=wn

It said that new patients and any existing patients still on Iressa will probably be switched to Tarceva. I just wanted to give you all a heads up!

CathyR

[TAnn]

I simply just can't believe this. What do you all think about this? What about those of us it has kept stable long past what anybody thought? Tarceva is so new, who knows what study they will come up with next year about it's survival rates. I'm not sure if this is positive news or not. Iressa has helped many of us on this board. What do y'all think?

TAnn

[Snowflake]

Here's the press release from the Astra Zeneca site:

http://www.astrazeneca.com/pressrelease/4245.aspx

[Andrea]

How disappointing. My dad said he heard somethng about it on the news today too.

[TAnn]

Looks like after reading AstraZeneca's press release (thanks Becky!) that I'll be talking with my doctor on Jan. 5th about switching to Tarceva. This news really disturbs me......

TAnn

[Bill]

I simply just can't believe this. What do you all think about this? What about those of us it has kept stable long past what anybody thought? Tarceva is so new, who knows what study they will come up with next year about it's survival rates. I'm not sure if this is positive news or not. Iressa has helped many of us on this board. What do y'all think?

TAnn

//////////////////

Drugs in the same class ( i.e. same MOA ) usually deliver comparable longer-term results. I would expect this to hold true for Iressa and Tarceva, as well.

[barbara w]

I feel as if the floor has caved in. My dad began Iressa on Tuesday, and we were pinning so many hopes on it. I just can't believe this. Where will we go from here?

[marion]

Just as soon as I begin to relax a little about this MESS; something else comes up. I have been on it since August 2004 and everything is suppose to be o.k.

Guess I will have to look on the positive side and maybe the new drug is even better and will work on us. marion

[Fay A.]

Well......I guess what I have to do personally is state that Iressa improved my ability to breath. Before I started on Iressa I sometimes felt as if I were going to drown without benefit of an ocean or lake or bathtub or bucket of water. It made the horrible-seal bark-scared folks into thinking I had TB or SARS and frightened young children-cough go away. I loved having that cough gone. It's back now. I can make myself look as if there is very little wrong with me, but that cough gives me away, and I hate it.

I had lesions showing up on PET and NEOTECT Scanning that disappeared shortly after starting Iressa. It kept me stable for a period of time, but eventually stopped working.

Iressa is not a cure. But it still works well for some of us.

[Lisa O]

The report does not change the fact that for some people Iressa still works wonders, either with symptom relief, stability, tumor reduction...

Everyone must talk to their own doctors about their own situation. This may not have been a study limited to BAC characteristics, or younger woman or nonsmokers... We all know that all drugs do not work the same for everyone.

If Iressa is working for you, it is between you and your oncologist unless it is pulled from the market. At this time it appears that it is going to be made available to those for whom it is working. I am a nonsmoking woman with BAC.

I am going to take Iressa as long as they will let me and as long as it continues to work. I am on an IRESSA list with many people in my situation who feel the same way. I am thankful to have Tarceva as the next step.

[Andrea]

I don't know if this is worth bubkas, but I wonder if people in the study were "tested" before hand to see if they were likely to benefit from Iressa. I remember after my mom's surgery the oncologist send out the tissue for further testing and said her tumor had a characteristic or protein or a something that they look for in Iressa use. Not all lung cancers have that particular "thing". I know, I sound so scientific

Anyway, just my random thoughts. Each oncologist should know what is best. And thankfully Tarceva just came out if Iressa is not right for someone.

[TAnn]

I agree with Lisa O. However, it sounds like the AstraZeneca press release is unsure if they will continue to produce Iressa in the long run. I know they will continue to make it available for those of us it is helping, but will they eventually pull it? This begs the question about Tarceva, basically the "sister" to Iressa. Will they have the same findings in a year? Look at Vioxx and Celebrex, I was wondering when they would question Celebrex, as it too is the "sister" of Vioxx.

I think there are still alot of unknowns as Lisa said and it is best to follow our doctor's advice. Still, it is very disturbing.

TAnn

[Fay A.]

Andrea,

I was enrolled in an Iressa Clinical Trial in 2002. I suspect that by that point the researchers had an inkling that Iressa was more effective on some histologies and not others. In early 2002 I was given an opportunity to participate in a trial that would help the researchers develop a test that would determine if a person's lung cancer would be responsive to Iressa. This involved taking scrapings of the mucus membranes inside my cheeks/mouth.

I think that as patients and caregivers we have to start by looking at as much information as is available to us, so that we formulate a reasoned response to this latest news, and not a knee jerk reaction.

And I think part of the problem with Iressa (and many other drugs)is that it is being prescribed for all types of Lung Cancer. I have a GED, Folks. I am no Rocket Scientist. But I have read everything I can find on the subject and even I know that the trials clearly showed that Iressa was effective for only a percentage of Lung Cancers. I know that a test was created to identify WHICH tumors had the best chance of being responsive to Iressa, and that test is available. And I know that at no point was Iressa ever touted as a "cure".

I am trying to find the post(s) where someone from this board provided information on where we can have tumor tested. I believe it was Harvard University Medical Center, but if anyone has memory of that information I would appreciate it if they would post the link again.

And if you will do a bit more reading on the subject you will discover that there are small but significant differences between Iressa and Tarceva. So while someone may not have a good response to Iressa they may very well have a good result with Tarceva. Or no response at all. One of the things we all have to remember is that our cancers are as individual as our own DNA. We're all going to react differently to some extent. If Lung Cancer were one disease, period, they would probably have a cure by now.

[stand4hope]

Teresa posted info about this also in the NSCL forum. I responded there, and am just copying and pasting my response here:

I guess I'm not concerned, unless they take it off the market. After his second-line chemo (or is it 4th-line since he had 4 drugs???), my husband had new growth. Except for the new brain results we got today, Iressa has kept him stable. I have faith in the product, and I don't see anything about it being harmful, so as long as it's keeping him stable, and they DON'T take it off the market, I hope he stays on it.

If it ain't broke, don't fix it! Huh?

We saw his onc today (about 2:15 p.m.) and he didn't say anything about the report, so I assume he hadn't seen it. He did mention Tarceva and/or Alimta as our next possibilities, if needed. We'll wait and see what the oncs say, but I don't see any reason to panic.

Love to all,

Peggy

[Wendy]

This is definetly a blow to us all - especially those that have had the disease stabalized with Iressa. I had hoped that it would be one of those "miracle" drugs. It will interesting to see what changes will be made in the future to those that are responding with the med.

I have my next doctors appointment on Tuesday, since I am on a preventative trial we will surely discuss it.

Thanks for the information!

Wendy

[teresag]

As others have said, please do not jump off the Iressa bandwagon yet. It may well work for people with the right receptors (targets). (After all, it is known as a "targeted" therapy.) Even the early studies showed that only a subset of people benefited from it. At the time, it was not clear who those people were. Now it is believed that they possess specific receptors that can be identified.

The difference between Tarceva and Iressa is that Tarceva went through the usual lengthy FDA process. This is a process that requires more study before a drug is approved. Iressa, being the first drug in its class for a disease considered lethal (lung ca unresponsive to two prior chemos), received what is called "expedited approval." With expedited approval, the drug manufacturer is required to continue studying the drug & to submit more data as the drug is put into use. That is why these data on Iressa are only now being analyzed.

Link to the thread I started in the NSCLC/mesothelioma forum with more information:

http://lchelp.com/community/viewtopic.php?t=13030

Please do not give up hope, anyone, and definitely don't stop taking any drug without talking to your doc(s). This news requires that you take action if you are on Iressa, but it does not show that the drug is worthless.

[Andrea]

Fay---is this the link about tumor testing?

http://lchelp.com/community/viewtopic.p ... or+testing

[Amy P]

My Mom's oncologist was one of the Dr's on the FDA comittee that gave the expedited approval for Iressa and she told us that as they continued to monitor those on Iressa that we would start seeing updated results.

I have not told my Mom about this - she has been dealing with stomach issues and is working with a GI to make sure her issues are Iressa related and not anything else (she has always had a sensitive stomach so that is not out of the question), plus she has been in a really good spirits lately. That might be wrong but since Iressa is working for her, I am not going to rock the boat until we go back to the doc in January or unless we hear anything else before then.

Also, she was on Vioxx and now Celebrex...sheesh can we catch a break on the drugs

[Lisa O]

This interview is very enlightening.

http://www.pharmalive.com/News/index.cf ... egoryid=54

Again, a subset of the population still benefits significantly from Iressa and for the time being will be allowed to continue to take it. Decisions have not been made beyond that.

[Bill]

IMO here's the key take-away from the interview that LisaO posted :

" There's no evidence from those studies that 250mg is an inadequate dose. So we don't have any reason to believe that we've under-dosed the patients here. But, given that we haven't show a survival benefit, whereas Tarceva - which is dosed at a higher equivalent dose - has, then one of the obvious questions is whether or not the dose of Iressa chosen is actually adequate to prolong survival. " ( end )

IMO once the Iressa dosage is adjusted upward ( assuming adverse side effects don't prohibit this ) I'd expect survival results to improve in line with that of Tarceva. Also, depending on the Tarceva side effects data, the currently recommended Tarceva dosage may have to be adjusted. All part of the learning curve for these two drugs. IMO, assuming both drugs stay on the market, once their dosages are properly adjusted I'd expect both drugs to deliver comparable longer term results within the same target groups.

[Fay A.]

"IMO once the Iressa dosage is adjusted upward ( assuming adverse side effects don't prohibit this ) I'd expect survival results to improve in line with that of Tarceva. "

I have to agree with this. I was taking 500 mg of Iressa a day during the first months of the Clinical Trial, but when the dosage was dropped to 250 I had disease progression.

[Lisa O]

Bill and Fay...

Great point!

[Fay A.]

Andrea,

Thanks. That isn't the link I was referring to, but it is a link I was looking for!

Here's a link to the info on Harvard's tumor testing to determine if EGFR inhibitors will be effective.

http://www.partners.org/Pharma_Testing_Popup.html

[Lisa O]

This link is encouraging. Straight from the "horses" mouth:

http://www.astrazeneca-us.com/modules/P ... ?id=211316

[Carla]

Sorry I've been absent. My dad has been feeling pretty good and while it's been like waiting for the other shoe to drop, sometimes it seems like you can almost forget about the whole thing (not really, but you know what I mean). I do check in periodically, though.

ANYWAY, his oncologist put him on IRESSA about a month ago, ALONG with Gemzar. I thought this was wierd because the Gemzar was just starting, and I thought you had to have 2 failed rounds of chemo before you did Iressa. He had done one round of Carbo/Taxol. I did ask the oncologist a while back about that study about the people with a certain genetic mutation responding better to Iressa and she first said, well, we'd have to get tumor tissue, but I reminded her that there was supposed to be teh rest of the spinal tumor frozen somewhere. So apparently at some point she did do some kind of EGR test, according to what she said yesterday, and he has the kind of whatever that you are supposed to have. BUT she said, based on this last word from the mfg., to finish out this month's prescription and then don't refill. He just had scans, etc., before starting, so it's not like she really knows if it worked or not. I do know the original tumor shrunk some, after the carbo/taxol and radiation, before starting Iressa, although the PET lit up on an adrenal gland and there is some wierd stuff on the spine and other lung that the radiologist will look at. Plus he has to have a biopsy on a nodule on the thyroid, which may or may not be related. And he's going for an MRI next week on teh spine.