ODAC gets what it wants
AstraZeneca plc's Iressa gefitinib for non-small cell lung cancer owes its FDA approval to the strong opinions of clinical practitioners who cut through the agency's ambivalence about precedence and statistics.
Senior FDA officials went into the Sept. 24, 2002 Oncologic Drugs Advisory Committee meeting with strong reservations about the Iressa NDA. But largely as a result of the vote of confidence in the drug from the committee's clinicians, the agency decided over the following seven months to approve the drug.
The Iressa decision also demonstrates that there is some flexibility in the