AstraZeneca has obtained approval from the US Food and Drug Administration (FDA) for its Iressa (gefitinib) 250mg once-daily tablets as a first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
Approval was granted for Iressa to treat patients with 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.
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Iressa is an oral and EGFR tyrosine kinase inhibitor (TKI) that works by inhibiting the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the growth and survival of cancer cells.
AstraZeneca global medicines development oncology head Antoine Yver said: "The approval of Iressa provides physicians and patients in the US with a new choice of first-line treatment for metastatic non-small cell lung cancer."
Approval was based on data from the Phase IV Iressa follow-up measure (IFUM) study, which evaluated the drug as a first-line treatment for Caucasian patients with locally advanced or metastatic EGFR mutation-positive NSCLC.
The Phase IV IFUM study data was supported by results from the Iressa Pan-Asia studt (IPASS) clinical trial.
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By GlobalDataIn August 2014, Iressa received FDA orphan drug designation to treat EGFR mutation-positive NSCLC.
AstraZeneca collaborated with Qiagen to offer therascreen EGFR companion diagnostic test for Iressa in the US.
In 91 countries, Iressa received approval to treat adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC.
In addition, the company is studying 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 wider range of lung cancer patients.
Image: Non-small cell carcinoma. Photo: courtesy of Yale Rosen.
