IRESSA® (Gefitinib)

The FDA on July 13, 2015 approved IRESSA® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA approved test. IRESSA® was approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test, for patient selection. IRESSA® tablets are a product of AstraZeneca Pharmaceuticals LP.