Federal health regulators have approved a new treatment for patients suffering from metastatic non-small cell lung cancer (NSCLC) whose tumors have certain types of epidermal growth factor receptor (EGFR) gene mutations, which can be detected by a companion diagnostic test.

On Monday, the U.S. FDA approved Iressa (gefitinib), a kinase inhibitor that works by blocking proteins responsible for boosting the development of cancer cells in patients with specific EGFR mutations. The drug is for patients whose tumors have the most common types of EGFR mutations in NSCLC.

"IRESSA is a once daily oral EGFR-tyrosine kinase inhibitor (TKI), which inhibits the activity that contributes to intracellular signaling pathways implicated in the growth and survival of cancer cells," AstraZeneca said in a statement. Iressa is marketed by the Delaware-based pharmaceuticals company.

"IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive advanced NSCLC."

Orphan product designation is granted to drugs designed for treating rare diseases. Financial incentives such as user fee waivers, tax credits and eligibility for market exclusivity is provided to promote the development of these drugs.

Lung cancer is the number one cause of death among Americans and while the condition tends to be more prevalent in men, the death count due to lung cancer in women is increasing.

This year, the National Cancer Institute estimates that there will be about 221,200 diagnoses of lung cancer with 158,040 deaths from the disease. The most prevalent type of lung cancer is NSCLC affecting around 85 percent of lung cancer cases in the U.S. EGFR gene's mutation is present in around 10 to 15 percent of NSCLC tumors.

"Iressa offers another effective first-line therapy option for selected lung cancer patients. This approval provides further support for a highly targeted approach to treating cancer," said Richard Pazdur, from FDA's Center for Drug Evaluation and Research.

The therascreen EGFR RGQ PCR Kit was also green-lighted as a companion diagnostic test that would identify those who have tumors with the EGFR gene mutations. The test will help determine whether or not it would be suitable for a patient to use Iressa as treatment.

The safety and efficacy of Iressa was shown in a clinical trial involving 106 patients. Tumors were reduced in half of the participants after treatment with the effect lasting about six months. 

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