Why new lung cancer drug approval is important

FDA’s approval last week ofAstraZeneca's Iressa (gefitinib) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) is an important tool in fighting the disease.

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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. NSCLC is the most common type of lung cancer and Iressa treats patients whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, present in about 10% 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, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

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FDA granted Iressa orphan product designation for the treatment of EGFR mutation-positive metastatic NSCLC. Orphan product designation is given to drugs intended to treat rare diseases, which provides financial incentives – such as tax credits, user fee waivers, and eligibility for market exclusivity – to promote their development.

The therascreen EGFR RGQ PCR Kit, manufactured by QIAGEN Manchester Ltd. in the United Kingdom, was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa.

“The approval of the therascreen EGFR RGQ PCR Kit will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving Iressa as first-line therapy,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Companion diagnostics provide information that is essential for the safe and effective use of important medications.”

The efficacy and safety of Iressa for this use was demonstrated in a multicenter, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. Participants received Iressa 250 mg once daily. Results showed that tumors shrank in about 50% of patients after treatment and this effect lasted an average of 6 months.

Iressa may cause serious side effects including interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea and ocular disorders. The most common side effects of Iressa are diarrhea and skin reactions (including rash, acne, dry skin and pruritus, or itching

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