AstraZeneca lung cancer drug approved as first-line treatment

The drug was previously approved for use only in patients who did not respond to chemotherapy.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: “The approval of IRESSA provides physicians and patients in the United States with a new choice of first-line treatment for metastatic non-small cell lung cancer”.

IRESSA is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the growth and survival of cancer cells.

NSCLC is the most common type of lung cancer, and about 10 percent of NSCLC cases are caused by the mutated EGFR gene, the FDA said. The therascreen EGFR RGQ PCR Kit is a newly approved diagnostic that can help doctors detect patients with the genetic mutation who are candidates for treatment with Iressa. NSCLC is the most common type of lung cancer.

According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year.

IRESSA is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC. Approximately 50% of patients experienced tumor shrinkage, with responses lasting an average of 6 months.

The FDA said on Tuesday the certification was determined on end product from an effort of 106 sufferers along with prior with no treatment non-small cubicle lung cancer.

Serious adverse events associated with gefitinib include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea and ocular disorders.

Iressa is marketed by Wilmington, Del.-based AstraZeneca.