Corixa and GlaxoSmithKline announce submission of Bexxar data and documentation in
support of the response to the U.S. FDA's complete review letter
08/09/2001
Seattle and Philadelphia, August 9, 2001 – Corixa Corporation (Nasdaq: CRXA) and
GlaxoSmithKline (NYSE: GSK) today announced the recent submission of documentation, data
and analyses to the U.S. Food and Drug Administration (FDA) in support of the response to the
FDA’s Complete Review Letter received on March 16, 2001 regarding the Biologics License
Application (BLA) for Bexxar™ (tositumomab, iodine I 131 tositumomab), a novel
radioimmunotherapy. The companies are seeking marketing approval of Bexxar for the treatment
of relapsed or refractory, low-grade or transformed low-grade non-Hodgkin’s lymphoma.
The submission contains a complete response to all questions raised regarding the Chemistry,
Manufacturing and Controls section of the BLA, and to a majority of the questions regarding the
clinical section of the BLA. The remainder of the response will be submitted following final
compilation of an independent review of clinical response data from two recently completed
Bexxar trials, as well as technical database information which was discussed by the agency in the
last week. Corixa expects to submit the remainder of the response shortly. Additionally, the
companies expect the review period will commence upon FDA acceptance of all data submitted
in response to the FDA’s Complete Review Letter.
“We look forward to our continuing dialogue with the FDA and to progressing the review of the
Bexxar BLA as we continue to seek regulatory approval for this novel radioimmunotherapy,” said
Steven Gillis, Ph.D., chairman and chief executive officer of Corixa Corporation.
"GlaxoSmithKline is pleased with the progress that has been made to date in responding to the
request for information raised in the FDA Complete Review Letter," said Kevin Lokay, vice
president of Oncology at GlaxoSmithKline. "We have been working closely with Corixa to ensure
the submission meets FDA requirements. GlaxoSmithKline is committed to bringing this
innovative therapy to market and to the patients who can benefit from Bexxar."... |
