AstraZeneca has been notified by the FDA that IRESSA™is scheduled for discussion at the oncology drug advisory committee (ODAC) meeting on September 24.

“AstraZeneca is pleased to be completing this historic submission of the first new cancer drug to target the epidermal growth factor receptor,” said Gerard T. Kennealey, M.D., Vice President of Clinical Research, Oncology, for AstraZeneca. “Completing the submission and discussing the data with the ODAC committee in September are two important steps towards making IRESSA™available to US patients later this year.”

IRESSA™was recently approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of advanced non-small cell lung cancer. Regulatory filings are pending in other countries. Pending FDA approval, IRESSA™is expected to launch later this year in the US. IRESSA™represents a new class of anti-cancer drugs known as selective epidermal growth factor receptor (EGFR) 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. IRESSA™is administered as a once daily, oral tablet.

The submission is based on two phase II trials (IDEAL 1 and 2) involving approximately 400 patients in the US, Japan and Europe. Both studies were presented at the American Society of Clinical Oncology (ASCO) meeting in May. All patients in the IDEAL 2 study had locally advanced or metastatic NSCLC, and all had received at least two prior chemotherapy regimens, including platinum-based therapy and docetaxel. One in four patients enrolled in IDEAL 2 had already been treated with four or more chemotherapy treatments.

Other ongoing IRESSA™studies include, Phase III combination studies with chemotherapy in newly diagnosed NSCLC (INTACT 1 and 2), and early investigative studies and phase II studies in other tumour types and in combination with different treatment modalities are underway. Studies of IRESSA™in earlier stages of NSCLC will begin later in 2002.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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 gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.