FDA Grants Corixa's Appeal For BEXXAR
Corixa to Present BEXXAR Data at Future ODAC Meeting
SEATTLE & PHILADELPHIA--(BW HealthWire)--June 27, 2002--Corixa Corp. (Nasdaq:CRXA - News) and
GlaxoSmithKline (NYSE:GSK - News) today announced that the U.S. Food and Drug Administration (FDA) has granted
Corixa's appeal regarding the regulatory review status of BEXXAR® (tositumomab and iodine I 131 tositumomab), an
investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma.
As a result, Corixa has been granted an opportunity to present data on BEXXAR at a future Oncologic Drugs Advisory
Committee (ODAC) meeting. The FDA added that, upon timely receipt of certain follow-up information requested by the
agency, it is highly likely that the FDA would have enough time to prepare for a BEXXAR ODAC presentation before the
end of this year. BEXXAR is being co-developed by Corixa and GlaxoSmithKline in the United States.
"We are very encouraged by the FDA's granting of our appeal and appreciate the agency's expeditious resolution of this
issue," stated Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We maintain our belief that BEXXAR
should be approved based on the number of durable responses it has demonstrated across multiple clinical trials. We look
forward to presenting these data at an upcoming ODAC meeting. We are hopeful the meeting will occur before the end of
this year and we will disclose the expected timing of the meeting when it is confirmed."
"We share Corixa's conviction that BEXXAR should be approved and available to patients who can benefit from it," said
Kevin Lokay, vice president of Oncology at GlaxoSmithKline. "We continue to work closely with Corixa in responding to
the FDA and are preparing for the ODAC panel."
Following its successful appeal, Corixa will now provide the FDA with additional data the agency has requested in support
of the company's position. These data include an integrated analysis of efficacy across multiple clinical trials and other
supporting materials, all of which are now being compiled and will be provided to the agency shortly. The precise timing of
the ODAC meeting is dependent upon the receipt and review of any additional information submitted to the BEXXAR
BLA. Corixa and GSK will provide a regulatory update upon notification from the FDA of the precise timing of Corixa's
BEXXAR presentation at an ODAC meeting.
About the Appeal Process
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. In that complete review letter, the
agency questioned the approvability of BEXXAR in light of the availability of other approved therapies, and stated that it
had insufficient data to evaluate BEXXAR's safety profile. Corixa and GSK met with the FDA in April 2002. After that
meeting, the agency stated in a letter that although it was now able to assess BEXXAR's safety profile, it continued
to question the clinical benefit of BEXXAR and suggested that such benefit should be shown in additional, prospective
clinical studies.
In response, Corixa filed an appeal under guidelines outlined in the Food and Drug Modernization Act. In the appeal,
Corixa articulated its belief that BEXXAR merits approval for the treatment of relapsed, refractory non-Hodgkin's lymphoma
patients based on the high number of durable responses observed across multiple clinical studies. Corixa maintained
that the number of patients with independently confirmed durable responses has not been demonstrated in clinical trials
of other products. As a result, the company believes that BEXXAR does address a medical need that has not been met
through the administration of previously approved products in this patient population.<snip> |
