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| |  FDA Advisory Committee Recommends Accelerated Approval of ZD1839 (IRESSA, gefitinib) for Advanced Non-Small Cell Lung Cancer ZD1839 - First in a new class of anti-cancer drugs LONDON, ENGLAND -- September 25, 2002 -- AstraZeneca announced today that the Oncologics Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) have recommended accelerated approval for ZD1839 (IRESSATM, gefitinib) for the treatment of advanced non-small cell lung cancer (NSCLC) after disease progression, following at least two chemotherapy agents. The FDA will now review the ODAC recommendation and make their final decision regarding granting accelerated approval for ZD1839. There are currently no approved drugs for this setting. Lung cancer is the leading cause of cancer deaths in the United States, and NSCLC accounts for 80 percent of all lung cancer cases1. "There is a critical unmet need for new lung cancer treatments, and ZD1839 provides a targeted new approach in the treatment of the disease," said Gerard T. Kennealey, MD, Vice President of Oncology Clinical Research, AstraZeneca. "The ODAC decision is a vote of confidence in ZD1839 and the clinical benefit we have seen with this drug." The regulatory package currently before the FDA is intended to fulfil the requirements for ‘accelerated approval’ commonly referred to as sub-part H approval, which allows for early approval of promising drugs for diseases that are serious or life-threatening, where the new drug appears to provide benefit over available therapy. Accelerated approval can be granted on the basis of a surrogate endpoint, like tumour response, that is reasonably likely to predict clinical benefit and must be followed up with additional studies after the drug is approved. This recommendation follows encouraging results from two pivotal phase II studies, IDEAL 1 and 2*, which confirmed ZD1839 as an active and generally well-tolerated potential new treatment option for patients with previously-treated advanced NSCLC2. IDEAL 1 and 2 involved more than 400 patients and demonstrated that treatment with ZD1839 leads to objective response or disease stabilisation in approximately 50 percent of patients. Many patients in the IDEAL studies experienced relief of their symptoms and typically this relief occurred rapidly, in some cases within 8-10 days of starting ZD1839 treatment. ZD1839 is the first in a new class of anti-cancer drugs known as selective Epidermal Growth Factor Receptor (EGFR) inhibitors that target and block within the cell signalling pathways implicated in the growth and survival of cancer cells. If approved by the FDA, ZD1839 will be available as a once-daily 250mg oral tablet. ZD1839 was approved in Japan for the treatment of inoperable or recurrent NSCLC in July 2002 and is currently under review with several regulatory authorities. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of oncology, gastrointestinal, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.
IRESSA is a trademark of the AstraZeneca group of companies * IRESSA Dose Evaluation in Advanced Lung Cancer = IDEAL For further information on the Epidermal Growth Factor Receptor and its potential role in cancer treatment, please visit www.EGFR-INFO.com <http://www.EGFR-INFO.com>
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SOURCE: Shire Health International
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