AstraZeneca announced that it has received a licence by the European Medicines Agency (EMEA) for its oral targeted anti-cancer drug, gefitinib, for EGFR (epidermal growth factor receptor-tyrosine kinase) activating mutation positive patients with Non Small Cell Lung Cancer (NSCLC). NSCLC is the most common type of lung cancer and accounts for 80% of all lung cancer cases. [1] The licence means that for the first time, thousands [2] of patients undergoing first line treatment of NSCLC in the UK may benefit from a more effective, [3] oral alternative to doublet chemotherapy (UK standard of care) without many of the side effects associated with chemotherapy. [3]

Gefitinib is licensed for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase), in all lines of therapy. [4]

Gefitinib is the only oral targeted therapy available for first line use, having demonstrated superior efficacy vs. doublet chemotherapy for patients with a specific genetic mutation of their tumours (EGFR activating mutation positive tumours) and is one of just a handful of anti cancer drugs already available to target only those patients most likely to benefit.

EGFR mutation status of a patient's tumour is a strong predictor of benefit with gefitinib. [3,5] When compared to standard chemotherapy, not only did significantly more patients with EGFR mutation positive tumours respond to treatment with gefitinib (71.2% v 47.3%, p=0.0001) but they also lived significantly longer without their cancer growing (progression free survival) (median PFS 9.5 months vs 6.3 months; HR 0.48, 95% CI 0.36 to 0.64, p The licence is based on data from two pivotal Phase III studies, IPASS and INTEREST. In IPASS, gefitinib significantly delayed cancer progression (median PFS 9.5 months vs 6.3 months; HR 0.48, 95% CI 0.36 to 0.64, p