Wednesday March 13, 7:03 am Eastern Time
Press Release
SOURCE: Corixa Corporation
Corixa Receives Complete Review Letter On BEXXAR
SEATTLE--(BW HealthWire)--March 13, 2002--Corixa Corporation (Nasdaq:CRXA - news), a developer of immunotherapeutics, today announced the receipt of a complete review letter from the U.S. Food and Drug Administration (FDA) regarding the Biological License Application (BLA) for BEXXAR® (tositumomab, iodine I-131 tositumomab), an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma.
Bexxar is being co-developed by Corixa and GlaxoSmithKline in the United States.
In the Complete Review letter received in the evening of March 12, 2002, the FDA stated that in its opinion, Corixa's September 10, 2001 response to the Agency's March 16, 2001 Complete Review letter did not provide sufficient evidence of the safety and net clinical benefit of BEXXAR and further stated that additional clinical studies will be required to provide such evidence. Regarding Corixa's prior request for Accelerated Approval, the letter stated that the data reviewed by the Agency do not provide sufficient evidence that BEXXAR addresses an unmet medical need. Additionally, the letter stated that within 10 days from its receipt, Corixa must either amend its application, notify the Agency of its intent to file an amendment, withdraw the application or request an opportunity for a hearing on whether there are grounds for denying approval of the application. Corixa will formally request a meeting with representatives of the Agency for further discussion of a regulatory path for BEXXAR. It is expected that this meeting will occur within the next 45 days.
``We are extremely disappointed with the FDA's decision and intend to promptly pursue resolution with our partner, GlaxoSmithKline and the Agency,'' stated Steven Gillis, Ph.D., Corixa chairman and chief executive officer. ``We are formally requesting a meeting with the FDA and hope to reach mutual agreement on the specific steps still necessary for approval. We will provide additional guidance as to the regulatory pathway for BEXXAR after further discussions with GlaxoSmithKline and the FDA.'' |
