AstraZeneca gets FDA Approval for Lung Cancer Drug Iressa
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Iressa, an oral EGFR tyrosine kinase inhibitor (TKI). Iressa 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.
The approval is based on data from the Phase IV IFUM (IRESSA Follow-Up Measure) trial and will be used for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). Currently, Iressa is approved in 91 countries to treat adults with locally advanced or metastatic EGFR mutation-positive NSCLC.
The 250mg once daily tablets are approved for NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. This was supported by results from the IRESSA Pan-ASia Study (IPASS) clinical trial.
The company is also examining IRESSA in combination with other investigational medicines, including its anti-PD-L1 monoclonal antibody, durvalumab (MEDI4736) to evaluate its potential as a combination treatment for a broader range of lung cancer patients.