AstraZeneca announced that the US Food and Drug Administration (FDA) has approved IRESSA for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with certain characteristics.
IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive NSCLC.
Antoine Yver, head of Oncology, Global Medicines Development at AstraZeneca said: “The approval of IRESSA provides physicians and patients in the US with a new choice of first-line treatment for metastatic non-small cell lung cancer. AstraZeneca is at the forefront of research into targeted therapies for EGFR mutated lung cancer and is committed to improving the outlook for patients at all stages of the disease.”
The drug was once seen as a possible miracle drug in treating lung cancer, but was found to effective in a limited number of circumstances. IRESSA is approved in 91 countries for the treatment of adult patients a type of advanced lung cancer. AstraZeneca has administrative and production operations in northern Delaware.
