FDA Approves AstraZeneca's Iressa As Lung Cancer Treatment

LONDON (Alliance News) - AstraZeneca PLC on Monday said the US Food and Drug Administration has approved Iressa (gefitinib) as a first-line treatment in patients with metastatic non-small cell lung cancer whose tumors harbor specific types of epidermal growth factor receptor gene mutations, as detected by an FDA-approved test.

Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit 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.

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

AstraZeneca has partnered with Qiagen to provide the FDA-approved therascreen EGFR companion diagnostic test for Iressa in the US The test uses a tumor tissue sample to rapidly identify EGFR exon 19 deletions or exon 21 (L858R) substitution mutations status of a lung cancer patient's tumor. Patients whose tests are positive for the EGFR exon 19 deletions or exon 21 (L858R) substitution mutations may be eligible for treatment with Iressa.

The FDA approval of Iressa is based on data from the IFUM (IRESSA Follow-Up Measure) clinical trial which showed an Objective Response Rate (ORR) of 50 and 70% (BICR and investigators, respectively) with a median Duration of Response (DOR) of 6 and 8.3 months.

Lung cancer is the leading cause of cancer-related death among men and women in the US and, though more common in men, the number of deaths from lung cancer in women is increasing.

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. Mutations in the EGFR gene are present in about 10% of NSCLC tumors.

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