Because of the limited use of Iressa (gefitinib) for treating non-small cell lung cancer, it is unlikely that a company would make a generic version of this drug. Also, because clinical trials have shown that this drug does not help extend survival time in people with this cancer, companies no longer market Iressa for use in the United States.
Iressa® (gefitinib) is a prescription medication approved for the treatment of non-small cell lung cancer when other treatments have failed. It belongs to a group of medicines known as tyrosine kinase inhibitors.
Iressa was originally made by AstraZeneca UK Limited for AstraZeneca Pharmaceuticals, LP. AstraZeneca no longer markets Iressa for use in the United States, and neither Iressa nor generic Iressa is available in the United States.
However, if you search the Internet for "generic Iressa," you may find a number of companies selling it. It is important to note that these medicines may be fake, substandard, and potentially dangerous. There may be generic Iressa products available from another country, but there is really no way of knowing if you are getting a genuine product. You should not buy any generic Iressa until there is an approved generic available.
It is unlikely that a generic version of Iressa will be available any time in the near future. Iressa was approved by the U.S. Food and Drug Administration (FDA) in May 2003. The drug's approval was based on results of trials that looked at tumor response to the drug. In these studies, 10.6 percent of people with non-small cell lung cancer given Iressa had tumors that responded to the drug.
After its approval, Iressa was studied in large clinical trials that examined whether the drug could help people with non-small cell lung cancer live longer. In these trials, Iressa failed to prolong survival in people with non-small cell lung cancer. Iressa also failed to show benefit when added to standard first-line chemotherapy for non-small cell lung cancer.
As a result, the FDA restricted the use of Iressa to people who had previously benefited from its use, or people who are currently taking it and benefiting from it. Furthermore, other medications have been shown to help people with non-small cell lung cancer, including other tyrosine kinase inhibitors. It is recommended these other treatments be tried before Iressa.
Because of its very limited use, as well as the availability of other medicines that may provide more clinical benefit for the treatment of non-small cell lung cancer, it is unlikely that a generic manufacturer will choose to make a generic version of Iressa.