“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 Programme (EAP) for ‘Iressa’. This programme 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 programme, the vast majority in the United States.