FDA Approves New Use of Iressa (Gefitinib) for EGFR-mutated Lung Cancer

chest xray shows the lungs

The US Food and Drug Administration (FDA) has approved Iressa (gefitinib) for the primary treatment of non-small cell lung cancer that has spread, and that contains specific mutations in the EGFR gene. The FDA also approved a test for the gene mutations. Iressa had been approved by the FDA in 2003, but wasn’t limited to EGFR-mutated lung cancer, and when it didn’t work as well as expected, it was taken off the market in the US.

Non-small cell lung cancer is the most common type of lung cancer, but only about 10% of cases have EGFR gene mutations. Iressa is for people whose tumors have the most common types of EGFR mutations.

Iressa is a type of targeted therapy called a kinase inhibitor. For lung cancers caused by a mutation in the EGFR gene, Iressa works by blocking the EGFR protein that helps the cancer cells grow.

The FDA based its approval on a study of 106 people with EGFR-mutated non-small cell lung cancer that had spread, and had not been treated before. After treatment with Iressa, about half the patients saw their tumors shrink or disappear. The improvement lasted for an average 6 months.

Iressa is taken as a pill. The most common side effects are diarrhea and skin problems that can include rash, acne, dry skin, and itching. Less common, but more serious side effects are possible and can include lung disease, liver damage, gastrointestinal perforation, severe diarrhea, and eye problems.

Iressa (gefitinib) is marketed by AstraZeneca.

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