March 4, 2005
– This morning the Oncology Drug Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) held a public hearing on Iressa, a late stage lung cancer drug.
The hearing focused on whether the FDA and AstraZeneca LP (the drug's manufacturer) gave adequate notice to the medical community and the public about the trial results. It was agreed today by the panel that it was adequate notice.
Testimony was presented by Laurie Fenton, the president of the Lung Cancer Alliance, formerly ALCASE, and by Ros Brannigan, a Stage IV lung cancer survivor, Alliance volunteer and Iressa user. Sheila Ross, also of the Lung Cancer Alliance and a lung cancer survivor, is a member of the ODAC group.
While Iressa appears to have a marked impact on certain subsets of the population
– those with EGFR tumor mutations, women, non-smokers and those of Asian descent
– recent large scale trials in Europe again raised questions about the drug's efficacy in overall survival.
Analysis of the results of the impact of Iressa on subset populations will not be completed until June. Both FDA and the company assured that the drug would not be pulled from the market in the meantime.
In a statement issued after the hearing, AstraZeneca said that the company "is committed to maintaining access to Iressa for patients who may benefit and we believe removal from the market is unnecessary while further data are collected."
The following is the complete text of Laurie's statement:
Good morning. My name is Laurie Fenton and I am President of The Lung Cancer Alliance, the only national organization dedicated exclusively to lung cancer patient advocacy. Some here may know us by our former name, Alliance for Lung Cancer Advocacy, Support, and Education, or ALCASE. I am here today to speak on behalf of our constituents, lung cancer patients and their loved ones.
Lung cancer leads all cancer deaths in the United States. This year’s estimates reveal that over 170,000 people will die from the disease. This year roughly that same number will be newly diagnosed with it. Overall, the five year survival rate is 15 percent – most living no longer than a few months from diagnosis. Sadly, that is why there are currently so few survivor advocates.
This is the cancer that people get blamed for. Patients receive little compassion because it is thought that they must be smokers. The fact is: this year, more than 60 percent of all new cases of lung cancer will occur in people who have never smoked or quit decades ago. And even if everyone who currently smokes quits today, lung cancer is going to lead cancer deaths for decades to come.
Bottom line – this cancer kills more people than breast, prostate, and colon cancers combined. It has very few effective treatments and federal research funding is woefully inadequate.
The Lung Cancer Alliance understands that the FDA is required by statute to evaluate drugs by looking at safety and efficacy data in large populations of patients to determine whether benefits outweigh the risks.
Interestingly, as we have discovered, IRESSA does not fit neatly in this protocol box. While IRESSA’s current clinical trial data has not revealed dramatic survival benefits overall – it has shown striking benefits for a small subset of the larger population – with less side effects and quicker response rates.
In fact, the Lung Cancer Alliance received many calls from patients who were terrified that IRESSA, which has helped them so dramatically, could possibly be pulled off the market by the FDA or by the company. Patients spoke of stock piling the drug and beginning to take IRESSA every other day to make their supply last longer. I am glad that you will hear from some of these patients today.
The reality is that we have an unmet public health need – lung cancer’s mortality statistics can no longer be ignored. Beyond demanding that government redirect its own resources to effect change, we as advocates also want to nurture responsible drug development to help in our fight to eradicate this number one cancer killer.
Alimta and Tarceva, recently approved for the treatment of lung cancer, are important arrows in our treatment quiver. But IRESSA must also be recognized as an important weapon in this battle. Even if unable to meet the “broad population” standard – we cannot ignore the fact that IRESSA has shown striking benefits within a subset of the population. Lung cancer patients and their doctors need all – not limited – choices to treat this disease.
It is our hope that both the FDA and AstraZeneca find a way to allow doctors and lung cancer patients access to IRESSA while, at the same time, agreeing upon a way to further study and evaluate the drug.
It could provide a window of opportunity to better understand this horrible disease, who will most benefit from drug treatments and why.
Thank You.
Disclosure:The Lung Cancer Alliance receives grants from AstraZeneca for educational programs. My participation here today, however, has not been compensated by AstraZeneca in any way.
