Emerging Treatments in Lung Cancer

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Iressa

Important Note About Iressa:

In December 2004 results from a clinical trial indicated that Iressa (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 (NSCLC). Currently the FDA and the drug’s manufacturer AstraZeneca are “sorting out the regulatory implications” of the data from the clinical trial.

The drug remains commercially available, although AstraZeneca has suspended advertising and promotion of Iressa. Physicians have been advised of the clinical trial data by the FDA and AstraZeneca. Patients with questions are encouraged to discuss them with their physicians. To learn more:

• ALCASE Statement Presented at FDA Hearing on Iressa
• ALCASE President to Speak at FDA Hearing on Iressa
• Iressa Remains Commercially Available to Patients
• Iressa Shown Not to Extend Survival in Clinical Trial
• FDA Statement on Iressa for Patients with Lung Cancer (FDA Website)
• Letter to Doctors Currently Prescribing Iressa (Word document)
• Lung Cancer in the News (Where all news stories related to this topic are posted.)

Overview:

The U.S. Food and Drug Administration granted accelerated approval to Iressa tablets as a single agent treatment for patients with advanced non-small cell lung cancer (NSCLC) whose cancer has continued to progress despite chemotherapy treatment. The drug was shown in clinical trial involving 261 patients with NSCLC. The response rate (defined as at least 50 percent tumor shrinkage lasting at least one month) was about 10 percent. As required by the accelerated approval regulations, Iressa's developer will perform additional studies to verify the drug's clinical benefit.

Iressa is one of a new class of cancer treatments known as targeted therapies. These drugs, which include Tarceva and Erbitux are designed to block a particular protein, the epidermal growth factor receptor, that spurs the growth of cancer cells. Such drugs tend to have fewer side effects than conventional chemotherapy. In the clinical trial, the most common side effects for patients receiving Iressa were nausea, vomiting, diarrhea, rash, acne, and dry skin. Some patients taking Iressa have developed interstitial lung disease (ILD). ILD is a serious and life-threatening lung disease. Iressa may cause fetal harm when administered to pregnant women.

Treatment Overview:

Iressa is given orally as a single tablet of 250 mg. Patients with poorly tolerated diarrhea (sometimes associated with dehydration) or skin drug reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by starting again with the 250 mg daily dose.

News Releases:

• ALCASE Statement Presented at FDA Hearing on Iressa
• ALCASE President to Speak at FDA Hearing on Iressa
• Iressa Remains Commercially Available to Patients
• Iressa Shown Not to Extend Survival in Clinical Trial

To learn more about Iressa:

• FDA Consumer Information Page: Iressa
• FDA/CDER Drug Information Page (includes FDA label, Approval letter, Q&A, and FDA News Release)

For more detailed treatment information:

• ACS Cancer Drug Guide: gefitinib