Iressa regulatory update

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 11-3 that AZN has demonstrated Iressa is reasonably likely to provide clinical benefit for non-small cell lung cancer patients. ODAC members said they did not share FDA's concern about a failed Phase III trial of Iressa in combination with chemotherapy agents as a first-line therapy (see BioCentury Extra, Sept. 23). FDA told ODAC that the lack of clinical benefit in previously untreated patients created a dilemma regarding whether the Phase II data in third-line patients is reasonably likely to predict clinical benefit. ODAC said that it is clear that there was a clinical benefit in the single arm study of Iressa as a third-line therapy and that the questions asked in the first-line study are completely different. ...