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Gefitinib Approved in Canada for Advanced Non-Small Cell Lung Cancer

LONDON, December 19/PRNewswire/ -- AstraZeneca Plc announced today that Health Canada has granted approval of gefitinib (IRESSA(TM), ZD1839) for the treatment of patients with advanced non-small cell lung cancer (NSCLC). Gefitinib is the first in a new class of biological, anti-cancer drugs known as 'Epidermal Growth Factor Receptor tyrosine kinase inhibitors' (EGFR TKIs). To date, gefitinib has been approved for patients with advanced NSCLC in 11 countries and over 110,000 patients have received the convenient, once-daily tablet through compassionate use, clinical trials or since launch.

Dr Alan Barge, gefitinib Worldwide Medical Director commented: "Lung cancer is the leading cancer killer in the world, causing more deaths each year than breast, prostate and bowel cancer combined. Over the past three decades there have been few advances in treatment options for lung cancer patients. For patients with advanced disease, who have exhausted all currently available treatments, their survival time is short and only about 5% of patients go on to survive another year. New treatments for NSCLC are urgently needed. The approval of gefitinib in Canada today is extremely exciting, offering great hope to thousands of lung cancer patients and their families."

Health Canada's Therapeutic Product Directorate (TPD) granted conditional approval of gefitinib 250mg per day as monotherapy (third-line therapy) for the treatment of patients with locally advanced or metastatic NSCLC after the failure of prior platinum-based and docetaxel chemotherapy. NSCLC is a complex, severely symptomatic illness, which has a devastating impact on the patient and their family.

In 2000 there were over 1.2 million people diagnosed with lung cancer worldwide and more than 1 million people died from the disease. The Canadian Cancer Society estimates 21,200 new cases of lung cancer will be reported in 2003.

The approval in Canada is based on data from two large, randomised Phase II trials, IDEAL 1 and IDEAL 2 (IRESSA Dose Evaluation in Advanced Lung Cancer). The trials demonstrated approximately 40% of patients -for whom there were no other treatment options available- gained life-enhancing benefit from gefitinib in terms of tumour shrinkage and stabilised disease, which were often associated with improvement in the debilitating symptoms associated with lung cancer. The median time to symptom improvement was 8-10 days. Furthermore, approximately one third of the patients in the IDEAL studies -the majority of whom had a very poor prognosis- were alive one year after starting treatment. Side effects are less severe and debilitating than those associated with cytotoxic chemotherapy; the most common side effects with gefitinib -skin rash and diarrhoea- are typically mild and do not usually require any active management with other therapies.

Gefitinib has been approved for the treatment of advanced NSCLC in the US, Australia, Japan, Argentina, Singapore, Korea, Taiwan, Mexico, Malaysia and the Philippines and is currently undergoing review with several other regulatory authorities worldwide.

Source: AstraZeneca

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