12:00 AM
May 12, 2003
 |  BioCentury  |  Regulation

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 agency's requirement that post-marketing studies of cancer therapies be ongoing at the time of accelerated approval.

The application for accelerated approval of Iressa was problematic for FDA because in addition to Phase II trials demonstrating efficacy, the company conducted two large Phase III trials in which the drug was not effective (see BioCentury, Sept. 20, 2002). Using a tactic commonly employed in cancer drug development, AstraZeneca (AZN; LSE:AZN, London, U.K.) conducted the Phase II trials in a refractory population, while testing Iressa as a first-line therapy in the Phase III trial.

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