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JNCI Journal of the National Cancer Institute 2002 94(23):1738-1739; doi:10.1093/jnci/94.23.1738
© 2002 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 94, No. 23, 1738-1739, December 4, 2002
© 2002 Oxford University Press

NEWS

For Bexxar, FDA Meeting Offers Long-Awaited Chance at Approval

Ken Garber

The first 10% of the full text of this article appears below.

Twelve years after it was first used to treat cancer patients, Bexxar (iodine 131 tositumomab) has finally arrived on the doorstep of the U.S. Food and Drug Administration. On Dec. 17, the FDA’s Oncologic Drugs Advisory Committee will consider Bexxar for the treatment of patients with relapsed or refractory low-grade or transformed low-grade B-cell non-Hodgkin’s lymphoma (NHL).

It has been a long and frustrating journey for the drug, which is an I-131-radiolabeled monoclonal antibody. The original biologic license application for Bexxar was submitted in June 1999, but the FDA has repeatedly sent it back, and in March 2002, the agency demanded new clinical trials.

The drug’s sponsor, Corixa Corp., based in Seattle, Wash., filed a successful appeal and the path is now clear for approval—or rejection. . . . [Full Text of this Article]


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