FDA approves Iressa (gefitinib) to treat EGFR exon 19 deletions or exon 21 (L858R) substitution mutations in NSCLC

AstraZeneca announced that the FDA has approved Iressa (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

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

AstraZeneca has partnered with QIAGEN to provide the Therascreen EGFR companion diagnostic test for Iressa in the US. The test rapidly identifies EGFR mutation status through a tumour tissue sample, in order to guide the use of Iressa in the treatment of patients with metastatic NSCLC. The FDA approval of Iressa is based on data from the Phase IV IFUM1 (Iressa Follow-Up Measure) study, assessing Iressa as a first-line treatment for Caucasian patients with locally advanced or metastatic EGFR mutation-positive NSCLC. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial. IRESSA is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC.