BEXXAR Update: FDA returns Bexxar to active review status:
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Press Release Source: Corixa Corporation
Corixa and GlaxoSmithKline Provide BEXXAR Regulatory Update
Monday December 2, 4:01 pm ET
SEATTLE & PHILADELPHIA--(BUSINESS WIRE)--Dec. 2, 2002--Corixa Corp. (Nasdaq:CRXA - News) and GlaxoSmithKline (NYSE:GSK - News):
--FDA Confirms That Receipt of Additional BEXXAR Data Constitutes a Complete Response to March 12, 2002 Complete Review Letter
--ODAC Appearance and Return to Active Review Status Prompts Corixa's Withdrawal of Dispute Resolution
Corixa Corp. (Nasdaq:CRXA - News) and GlaxoSmithKline (NYSE:GSK - News) today announced that the U.S. Food and Drug Administration (FDA) has determined that additional BEXXAR® (tositumomab, iodine I-131 tositumomab) safety data submitted in March 2002 and submission of a response in October 2002 to the agency's complete review letter from March 2002 constitute a complete response to the questions and issues raised by the FDA in its most recent complete review letter. The FDA has further confirmed that the data submitted constitute substantial new information addressing prior concerns and now the agency chooses to take the data on BEXXAR to the Oncologic Drugs Advisory Committee (ODAC) for advice regarding approval.
The FDA also confirmed that the BEXXAR BLA has been returned to active review status. The new Prescription Drug User Fee Act (PDUFA) goal date for the FDA to complete its review of all materials regarding BEXXAR is May 2, 2003.
Corixa and GlaxoSmithKline announced earlier this month that BEXXAR safety and efficacy data will be presented to ODAC on December 17, 2002. Corixa is seeking approval of BEXXAR therapy for the treatment of relapsed or refractory low-grade or transformed low-grade non-Hodgkin's lymphoma. In addition, Corixa is seeking registration for use of BEXXAR in low-grade non-Hodgkin's lymphoma patients who do not respond or progress following rituximab therapy.
On May 31, 2002, Corixa filed a request for formal dispute resolution, appealing the position articulated by the FDA on the approval status of BEXXAR in its complete review letter dated March 12, 2002. On June 26, 2002 the FDA granted Corixa's appeal, paving the way for presentation of safety and efficacy data before ODAC. Since that time Corixa has provided the agency with additional safety and efficacy analyses in response to questions in the complete review letter as well as questions that arose during further analysis by FDA review staff. As a result of the scheduling of the ODAC meeting, the return of the BEXXAR BLA to active review status and the FDA's stance regarding the suitability of the BEXXAR safety and efficacy data for presentation to ODAC, Corixa has chosen to withdraw its prior request for formal dispute resolution.
"We are pleased to have received notification from FDA of the return of the BEXXAR BLA to active review status. We have worked closely with FDA review staff for the past several months and have provided prompt responses to multiple inquiries arising as a result of FDA's continuing review. We are looking forward to presentation of safety and efficacy data for BEXXAR at the December 17 meeting of ODAC," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We continue to believe that BEXXAR can be approved on the basis of safety and efficacy data submitted in our BLA including our replies to FDA complete review letters. These data now include the durability of response seen in a significant percentage of treated patients." [snip] |
