Corixa requests formal dispute resolution with FDA on Bexxar
SEATTLE & PHILADELPHIA -- Corixa Corp. and GlaxoSmithKline announced that Corixa has filed a request for formal dispute resolution, appealing the position articulated by U.S. Food and Drug Administration (FDA) on the approval status of Bexxar in its complete review letter dated March 12, 2002.
Corixa also requested the opportunity to present data on the safety and efficacy of Bexxar in the treatment of relapsed or refractory low-grade and transformed-low grade non-Hodgkin's lymphoma to a meeting of the Oncologic Drugs Advisory Committee (ODAC).
"This request initiates the dispute resolution process provided under the Food and Drug Administration Act," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "The filing also summarizes our strong belief that Bexxar should be approved on the basis of the number of durable responses demonstrated across multiple clinical trials."
Under FDA procedures, requests for formal dispute resolution are sent to the appropriate dispute resolution project manager at the Agency. Appeals are then reviewed by the appropriate Center for Biologics Evaluation and Research official as established under the Center's chain of command. A written response from the Agency should be provided within 45 days of receipt of the request for dispute resolution. If additional information is required for the official to make a decision, that time period may be extended.
Although no new information may be submitted as a part of a request for dispute resolution, if an appeal is granted, Corixa could then provide the FDA with additional data in support of the contention that Bexxar meets an unmet medical need that has not been observed with currently approved therapies. If an appeal is granted, the timing of an ODAC meeting would be dependent upon the receipt and review of additional information submitted in connection with the BLA. However, a presentation before ODAC this year remains a possibility, subject to approval of the appeal.
Posted: December 2002