Unfortunate news about Iressa (gefitinib).

[teresag]

Copy of an email sent to the members of the Oncology Nursing Society:

_____________________________________________________________

In collaboration with the Food and Drug Administration (FDA), and as a service to our members, the Oncology Nursing Society will provide drug development information about therapies for patients with cancer. This will allow the FDA to inform ONS members in a timely manner. The following is a message from Dr. Richard Pazdur:

To: ONS membership

From: Richard Pazdur, MD

Director, Division of Oncology Drug Products

Center for Drug Evaluation and Research, FDA

AstraZeneca notified the United States Food and Drug Administration (FDA) that a large randomized study comparing Iressa (gefitinib) plus best supportive care (BSC) to placebo plus BSC failed to demonstrate a survival advantage for gefitinib in the treatment of non-small cell lung cancer (NSCLC) patients who have received 1 to 2 prior chemotherapy regimens (Trial 0709). A letter to prescribing physicians from AstraZeneca regarding this trial is posted at http://www.astrazeneca-us.com/modules/P ... ?id=211316 .

Iressa was originally approved by the FDA on May 5, 2003, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression on both platinum-based and docetaxel chemotherapies. Iressa was approved based on a 10% response rate under accelerated approval regulations. These regulations allow approval based on a surrogate end point reasonably likely to predict clinical benefit and require subsequent demonstration of clinical benefit in further investigations. As an approval condition, AstraZeneca committed to conduct a randomized trial examining Iressa effect on survival in this patient population (Trial 0709).

AstraZeneca reports that Trial 0709 enrolled 1,692 patients from 210 study centers in 28 countries. The last patient was enrolled on August 2, 2004, and the data cut-off was October 29, 2004. The two treatment arms were well balanced for demographic and disease-related patient characteristics. AstraZeneca reports that gefitinib treatment was not associated with a significant survival improvement in the overall population HR=0.89 (95%CI: 0.78, 1.03, p=0.11) with a median survival of 5.6 months for gefitinib-treated patients and 5.1 months for placebo-treated patients. AstraZeneca reports that gefitinib treatment was not associated with a significant improvement in the adenocarcinoma population HR=0.83 (95% CI:0.67, 1.02, p=0.07) with a median survival of 6.3 months for gefitinib-treated patients and 5.4 months for placebo-treated patients.

AstraZeneca has suspended promotion of gefitinib while these trial data are further analyzed and will continue to make the drug available to patients who appear to benefit from treatment. Physicians are reminded that docetaxel (Taxotere) and erlotinib (Tarceva®) have received regular approval for this indication and that pemetrexed (Alimta®) has received accelerated approval. The product labels providing complete prescribing information are available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

_____________________________________________________________

I am sharing this information so that people on Iressa may take appropriate action in collaboration with their health care provider. Those of you taking Iressa may wish to talk to your health care professional about these findings. They are still analyzing the data to determine if a subset of patients with specific markers do benefit from the drug. In other words, the final conclusions have yet to be reached and any action you take in response to this information must be in cooperation with your physician.

Please note that the FDA URL above contains a list of drugs by brand name. The entry for Iressa does not yet include this updated information.

This information was also released on Yahoo Healthcare News.

[Andrea]

This is so disappointing. However I am hoping that Iressa does help a certain sector and once they find that sector, people can be treated accordingly.

I bet oncologist offices are being flooded with calls today

[kimblanchard]

I for one can testify it did not help my husband, he is very much worse after 6 weeks on it, very sick right now. Still, there does seem to be some it does help. Guess we will wait and see what all comes out on the news. Margaret

[Lisa O]

I believe that we have to be careful with interpretation of this study. There is still a group of people for whom Iressa can be very helpful. I believe people should speak with their physicians before abandoning faith in their treatment.

[Snowflake]

AstraZeneca notified the United States Food and Drug Administration (FDA) that a large randomized study comparing Iressa (gefitinib) plus best supportive care (BSC) to placebo plus BSC failed to demonstrate a survival advantage for gefitinib in the treatment of non-small cell lung cancer (NSCLC) patients who have received 1 to 2 prior chemotherapy regimens (Trial 0709). A letter to prescribing physicians from AstraZeneca regarding this trial is posted at http://www.astrazeneca-us.com/modules/P ... ?id=211316 .

Okay, here's my take-away. Note that the study being looked at and discussed is with Iressa as a second or third line chemo... Quite a few of the members here are not taking Iressa as such, after one or two previous chemos did not work.

I'm sure there are more studies in the works, such as the one Andrea's mother was on (same as mine) where Iressa was being used as suppressive therapy.

Don't panic, be concerned, talk to your doctor, but don't panic.

Becky

[stand4hope]

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

[teresag]

Allow me to repeat:

I am sharing this information so that people on Iressa may take appropriate action in collaboration with their health care provider. Those of you taking Iressa may wish to talk to your health care professional about these findings. They are still analyzing the data to determine if a subset of patients with specific markers do benefit from the drug. In other words, the final conclusions have yet to be reached and any action you take in response to this information must be in cooperation with your physician.

So, absolutely, this is not the end of Iressa, as Lisa O and Becky noted. Bottom line is: be aware, but don't stop taking it without talking to your doc.

[ErinC1973]

Well my mom called her oncologist at CTCA today and he said that this study was done in EUROPE. He's keeping her on it and said that if there was a cause for panic, he would be calling all of his patients immediately. And that makes perfect sense to me.

Furthermore, someone said here that you have to be careful interpreting findings like this, because there is obviously a group of people that IRESSA does benefit. Knowing what I do about this drug, and statistically speaking, those who have had results where other drugs have failed them, wouldn't you agree?

[Lisa O]

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

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