Special Notices

ALCASE President to Speak at FDA Hearing on Iressa

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review Iressa, a drug currently approved for advanced non-small cell lung cancer patients at its upcoming March 4 meeting.

The review comes after the December release of clinical trial data showing that IRESSA® (gefitinib) (250mg tablet) plus "best supportive care" provided no survival advantage over a placebo plus "best supportive care" in patients with advanced non-small cell lung cancer.

Iressa's manufacturer, AstraZeneca, will "share with the panel the preliminary Iressa (gefitinib) trial 709 data, summarize AstraZeneca’s communication activities to date to inform physicians and patients, and discuss the timelines and next steps being undertaken to fully analyze this trial," according to a statement released by the company.

As the only organization dedicated to lung cancer patient advocacy, ALCASE will be present at the meeting. Laurie Fenton, ALCASE's president, is planning to speak at the open mike portion of the meeting to help convey the patient perspective on this matter.

The FDA has told AstraZeneca that no regulatory decision or panel vote regarding Iressa is anticipated at the March 4th meeting and that consideration of other regulatory actions, such as removal of the drug from the market, is not anticipated until the data are fully analyzed.

About March 4 ODAC Hearing
AstraZeneca's ODAC Meeting Briefing Document (pdf)
AstraZeneca Statement (pdf)
In the News:
Fate of AstraZeneca's Iressa to be Discussed by ODAC March 4
AstraZeneca Seeks Cmte. Input On Future Iressa Marketing Steps
FDA panel to review cancer drug

About Clinical Trial Results
Iressa® Remains Commercially Available to Patients
Iressa® Shown Not to Extend Survival in Clinical Trial
FDA Statement
Gefitinib (IRESSA™) Lung Cancer ISEL Trial Results (News release from AstraZeneca)
Doctor Letter Regarding Iressa (gefitinib) ISEL Data

About ODAC
The Oncologic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs