Iressa Fails to Prolong Survival in Lung Cancer Clinical Trial

Yael Waknine


December 20, 2004

Dec. 20, 2004 — The U.S. Food and Drug Administration (FDA) has released a statement informing consumers and healthcare professionals of the failure of gefitinib (Iressa, made by AstraZeneca) to demonstrate a prolonged survival benefit compared with placebo in a large clinical trial involving 1,692 patients with non-small cell lung cancer (NSCLC) refractory to two or more courses of chemotherapy.

The postmarketing study to verify the clinical benefit of gefitinib was conducted in accordance with the conditions imposed by the FDA in its accelerated approval of the drug in May 2003. The approval was based on the results of clinical trials showing that gefitinib therapy significantly shrank tumors in approximately 10% of patients with refractory NSCLC, with the possible clinical benefit of increasing patients' overall survival time.

The FDA advises patients receiving gefitinib to continue therapy and consult with their physician as soon as possible. The FDA notes that alternative therapies with docetaxel (Taxotere, made by Aventis Pharmaceuticals) and erlotinib (Tarceva, made by OSI Pharmaceuticals) are available and have been shown in studies to improve survival in patients with NSCLC that has progressed with previous therapies.

The FDA has the authority to remove gefitinib from the market based on the lack of survival benefit demonstrated in the trial. Study results are currently being evaluated to determine whether removal from market or other regulatory actions are warranted.

Reviewed by Gary D. Vogin, MD


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