AstraZeneca has announced that the final documents of the NDA, for IRESSA (ZD1839) have been submitted to the U.S. FDA completing the rolling submission for the drug that began last summer.
All clinical data including safety and efficacy information was provided to the agency in December.
IRESSA is being considered as a monotherapy agent for the treatment of advanced non-small cell lung cancer (NSCLC) after disease progression following chemotherapy.
“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.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical pharmaceuticals and the supply of healthcare services.