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FDA Advisory Committee votes for accelerated approval of Iressa

LONDON, U.K., Sept. 25, 2002 -- AstraZeneca announced that the Oncology Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 11 to 3 that results in third line advanced non-small-cell lung cancer (NSCLC) were "reasonably likely to predict clinical benefit", which the FDA indicated was a vote for accelerated approval for Iressa (ZD1839) for the treatment of advanced NSCLC after disease progression following at least two chemotherapy agents (third line).

The FDA will now review the ODAC recommendation and make a final determination regarding granting accelerated approval for Iressa. 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 cases.

"There is a critical unmet need for new lung cancer treatment, and Iressa 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 deliberations were a vote of confidence in 'Iressa' and the clinical benefit we have seen with this drug."

The regulatory package for Iressa currently before the FDA is intended to fulfill 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 tumor response, that is reasonably likely to predict clinical benefit and must be followed up with additional studies after the drug is approved.

If approved by the FDA, Iressa will be the first drug available in the US from a new class of anti-cancer drugs known as selective epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitors that target and block, within the cell, signaling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumors. If approved, Iressa will be sold as a once daily, 250mg oral tablet.

Iressa was approved on July 5, 2002, by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of advanced NSCLC, and regulatory filings are pending in other countries.

AstraZeneca currently has a global Expanded Access Program (EAP) for Iressa. This program was instituted to provide 'Iressa' to NSCLC patients who do not qualify for clinical trials and who have exhausted other treatment options. To date, over 18,000 patients have received Iressa through this compassionate use program, the vast majority in the United States.

Source: AstraZeneca

Posted: September 2002