AstraZeneca UK Ltd, 600 Capability Green, Luton LU1 3LU, has submitted a Single Technology Appraisal (STA) for Gefitinib (IRESSA) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the Epidermal Growth Factor Receptor (EGFR-TK). Gefitinib is a selective EGFR-TKI, effective in NSCLC patients with EGFR-TK mutations. It is indicated for adult patients with NSCLC with activating EGFR-TK mutations. Gefitinib is expected to be available in the UK in early September 2010. It has regulatory approval in the EU and other countries. The technology is currently not widely used in the NHS but is being evaluated for use in the first-line treatment of NSCLC patients with EGFR-TK mutations. The NHS is working with AstraZeneca to ensure equitable access to EGFR-TK mutation testing for identifying eligible patients. Gefitinib is available as 30 x 250mg film-coated tablets. The recommended dose is 250 mg daily until disease progression. The NHS list price for IRESSA is £2167.71, with a single Fixed Price for each patient treated. The treatment setting is first-line treatment for previously untreated adult patients with locally advanced or metastatic NSCLC with activating EGFR-TK mutations. Gefitinib offers reduced stress on chemotherapy services, fewer emergency admissions, and lower costs associated with chemotherapy toxicity. It is administered orally, making it easier to use than intravenous chemotherapy. Gefitinib has demonstrated superior efficacy to doublet chemotherapy in EGFR-TK M+ NSCLC patients. The IPASS trial showed that gefitinib significantly improved progression-free survival and quality of life in EGFR-TK M+ patients compared to doublet chemotherapy. The NICE guidelines recommend doublet chemotherapy as the first-line treatment for NSCLC, but gefitinib is more effective in EGFR-TK M+ patients. The use of EGFR-TK mutation testing is not routine in the NHS, but AstraZeneca is working with the NHS to ensure equitable access. The technology is subject to health technology assessment in the UK, with a submission to the Scottish Medicine Consortium expected in January 2010. The clinical evidence from the IPASS trial and other studies supports the efficacy of gefitinib in EGFR-TK M+ NSCLC patients. The meta-analysis of PFS results from IPASS and other trials showed that gefitinib significantly improved PFS compared to doublet chemotherapy. The health economic evaluation will consider the cost-effectiveness of gefitinib in the NHS. The technology is intended for use in the right patient pool, i.e., NSCLC patients with EGFR-TK M+ tumours, where itAstraZeneca UK Ltd, 600 Capability Green, Luton LU1 3LU, has submitted a Single Technology Appraisal (STA) for Gefitinib (IRESSA) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the Epidermal Growth Factor Receptor (EGFR-TK). Gefitinib is a selective EGFR-TKI, effective in NSCLC patients with EGFR-TK mutations. It is indicated for adult patients with NSCLC with activating EGFR-TK mutations. Gefitinib is expected to be available in the UK in early September 2010. It has regulatory approval in the EU and other countries. The technology is currently not widely used in the NHS but is being evaluated for use in the first-line treatment of NSCLC patients with EGFR-TK mutations. The NHS is working with AstraZeneca to ensure equitable access to EGFR-TK mutation testing for identifying eligible patients. Gefitinib is available as 30 x 250mg film-coated tablets. The recommended dose is 250 mg daily until disease progression. The NHS list price for IRESSA is £2167.71, with a single Fixed Price for each patient treated. The treatment setting is first-line treatment for previously untreated adult patients with locally advanced or metastatic NSCLC with activating EGFR-TK mutations. Gefitinib offers reduced stress on chemotherapy services, fewer emergency admissions, and lower costs associated with chemotherapy toxicity. It is administered orally, making it easier to use than intravenous chemotherapy. Gefitinib has demonstrated superior efficacy to doublet chemotherapy in EGFR-TK M+ NSCLC patients. The IPASS trial showed that gefitinib significantly improved progression-free survival and quality of life in EGFR-TK M+ patients compared to doublet chemotherapy. The NICE guidelines recommend doublet chemotherapy as the first-line treatment for NSCLC, but gefitinib is more effective in EGFR-TK M+ patients. The use of EGFR-TK mutation testing is not routine in the NHS, but AstraZeneca is working with the NHS to ensure equitable access. The technology is subject to health technology assessment in the UK, with a submission to the Scottish Medicine Consortium expected in January 2010. The clinical evidence from the IPASS trial and other studies supports the efficacy of gefitinib in EGFR-TK M+ NSCLC patients. The meta-analysis of PFS results from IPASS and other trials showed that gefitinib significantly improved PFS compared to doublet chemotherapy. The health economic evaluation will consider the cost-effectiveness of gefitinib in the NHS. The technology is intended for use in the right patient pool, i.e., NSCLC patients with EGFR-TK M+ tumours, where it