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Title: American Society Of Clinical Oncology Recommends Gefitinib (Iressa, ZD1839) in Lung Cancer Treatment Guidelines' Update

"American Society Of Clinical Oncology Recommends Gefitinib (Iressa, ZD1839) in Lung Cancer Treatment Guidelines' Update"

LONDON, ENGLAND -- February 2, 2004 -- The American Society of Clinical Oncology has updated their clinical practice guidelines and recommended gefitinib (IRESSA™, ZD1839) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)(1) after failure of both platinum and docetaxel chemotherapies. Gefitinib is the first in a new class of anti-cancer drugs known as 'Epidermal Growth Factor Receptor tyrosine kinase inhibitors' (EGFR TKIs) and is the first biologically-targeted drug to be included in these internationally recognised NSCLC guidelines. Gefitinib is approved for treating advanced NSCLC in 18 countries, including the US, and over 123,000 patients have received the convenient, once-daily tablet through compassionate use, clinical trials or since launch. The addition of gefitinib to the treatment guidelines - published the Journal of Clinical Oncology(1) - demonstrates that EGFR-TKIs have a valuable place in clinical practice and recognises for the first time that there is now a treatment option for patients who have exhausted all other standard advanced NSCLC treatments. This guideline update comes in light of significant gefitinib clinical research: · Unprecedented response rates in disease already progressed on previous chemotherapy: In the pivotal IDEAL trials (gefitinib 250mg per day), in patients whose disease had already progressed on previous chemotherapy, as many as 40-50% of patients taking gefitinib have benefited. Up to 18% have demonstrated tumour shrinkage, up to 36% have achieved stabilised disease(2,3). · Rapid symptom relief: Furthermore, approximately 40% of patients in the IDEAL trials experienced relief from their debilitating lung cancer symptoms; generally symptom relief was rapid with a median time to improvement of 8-10 days(4). · Promising survival indications: Approximately 30% of patients in the IDEAL trials (most of whom had a very poor prognosis) were still alive one year after starting gefitinib - an extremely promising figure as data show patients with advanced disease, who have exhausted all available treatment options have a 1-yr survival rate of 5.5%(5). SOURCE: Shire Health International

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