The US Food and Drug Administration (FDA) has approved AstraZeneca's 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 is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer (NSCLC). 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.
Iressa is approved in 91 countries for the treatment of adult patients with locally advanced or metastatic EGFR mutation-positive NSCLC. The safety profile of Iressa is well established through a large, global clinical programme and extensive real world evidence. The most commonly reported adverse events for Iressa are diarrhoea and skin reactions including rash, acne, dry skin and pruritus.
AstraZeneca is also studying Iressa in combination with other investigational medicines, including the company’s anti-PD-L1 monoclonal antibody, durvalumab (MEDI4736) to assess its potential as a combination treatment for a broader range of lung cancer patients.
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