While FDA has not announced a recall of Iressa (that is not surprising considering that FDA has failed to recall other drugs that should not be on the market, for instance, Adderall, Crestor, Nexium, Prozac, Viagra, etc.) but the new label will essentially show that drug should be used only for those cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib (Iressa) treatment. In addition to the new labeling, FDA has agreed to AstraZeneca's proposal to limit distribution of this drug under a risk management plan called the Iressa Access Program.
The FDA added that new patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer. FDA has approved Taxotere (docetaxel) and Tarceva (erlotinib), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies. Alimta (pemetrexed) has received an accelerated approval based on the surrogate endpoint for this use but has not yet demonstrated any survival benefit.The FDA confirms that while this is not a recall, the agency may recall it later after reviewing the data.
FDA approved Iressa in May 2003, under the Agency's accelerated approval (Subpart H) program, for the treatment of patients with non-small cell lung cancer who had failed two or more courses of chemotherapy. Iressa is currently approved in 36 countries.
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