Corixa and GlaxoSmithKline Report Progress
on FDA Review of BEXXAR Therapy Application
Monday May 5, 7:04 am ET
SEATTLE & PHILADELPHIA--(BUSINESS WIRE)--May 5, 2003--Corixa Corporation
(Nasdaq:CRXA - News) and GlaxoSmithKline (NYSE:GSK - News) today announced that
many of the steps required for approval of BEXXAR® therapy (tositumomab and iodine I
131 tositumomab) are complete.
However, the U.S. Food and Drug Administration (FDA) has extended its review of the
BEXXAR therapy application for up to an additional three months. The three-month
extension provides additional time to further refine post marketing commitments and
package insert language and to ensure that they are consistent with an updated safety
database requested by the FDA and submitted by Corixa in early April 2003.
BEXXAR therapy safety data presented at the Oncologic Drugs Advisory Committee in
December 2002 included safety data on a population of 620 patients. The updated
safety database contains safety information on 995 treated patients with up to 9.5
years of follow up. The overall safety profile of BEXXAR therapy was not altered by the
inclusion of the additional data.
As a result of this action, the FDA now has up to three months to complete its review of
BEXXAR therapy but can take action at any time. The new Prescription Drug User Fee
Act (PDUFA) goal date for the FDA to complete its review of BEXXAR therapy is August
1, 2003.
A majority of the steps required for approval already have been completed, including:
Satisfactory completion of all required manufacturing site inspections;
Agreement on several elements of post approval studies;
Submission of first and second drafts of the package insert; and
Completion and submission of information and procedures for drug ordering,
dose preparation, dosimetry methods, and dose administration.
"Corixa and GlaxoSmithKline are continuing to work closely with the agency to finalize
remaining documentation required for approval, and to make BEXXAR therapy
available to the many patients with follicular non-Hodgkin's lymphoma (NHL) who could
benefit from this therapy," said Steven Gillis, Ph.D., chairman and chief executive
officer of Corixa Corporation. "In addition to our progress with the FDA, we continue to
work closely with GlaxoSmithKline to ensure that marketing, reimbursement and sales
resources, as well as other procedures are ready for rollout upon approval."
"We believe that we and Corixa, working together with the FDA, will be able to quickly
finalize remaining documentation," said Kevin Lokay, vice president of Oncology at
GlaxoSmithKline. "We look forward to a final decision regarding BEXXAR approval and
continue to believe that BEXXAR therapy will give the oncology community a
therapeutic option that has longer follow-up data than other newly approved cancer
therapies and will provide additional therapeutic options for patients in need. We've
recently expanded our oncology resources, thoroughly trained our sales force and are
prepared for a successful launch of BEXXAR therapy."
BEXXAR Therapy
Corixa and GlaxoSmithKline are seeking approval of BEXXAR therapy for the treatment
of patients with B-cell, follicular, non-Hodgkin's lymphoma (NHL), with and without
transformation, whose disease has relapsed following or is refractory to chemotherapy
and is refractory to rituximab.
BEXXAR is a dual-action therapy that pairs the tumor-targeting ability of a cytotoxic
(cancer killing) monoclonal antibody (tositumomab) and the therapeutic potential of
radiation (iodine 131) administered as a patient-specific dose. Iodine 131 has a
well-established safety profile in the treatment of thyroid disease and tositumomab has
anti-tumor activity of its own. Combined, these agents form a radiolabeled monoclonal
antibody (iodine I 131 tositumomab) that binds to the target antigen CD20 found on
NHL cells, thereby initiating an immune response against the cancer and delivering a
dose of radiation directly to tumor cells. BEXXAR therapy is the only NHL therapy that is
specifically dosed based on an individual's drug clearance rate, allowing the delivery of
a pre-determined amount of radiation to each individual patient.
Conference Call
Corixa and GSK will discuss the FDA's PDUFA response in a conference call and
webcast on Monday, May 5, 2003 at 8:00 a.m. ET/5:00 a.m. PT. To access the live
conference call, dial 800/289-0496 (domestic) or 913/981-5519 (international).
Webcast participants can sign up at the Investors page of Corixa's web site
(http://www.corixa.com/default.asp?pid=invest). A recorded replay of the conference
call can be accessed through the website, or by dialing 888/203-1112 (domestic) or
719/457-0820 (international), and entering passcode 301473. The call will be
rebroadcast until midnight ET, May 12th.<snip> |
