Corixa Corp. Gets FDA Complete Review Letter For Bexxar
DOW JONES NEWSWIRES
SEATTLE -- The Food and Drug Administration, in a review letter, told Corixa Corp. (CRXA) it must complete additional clinical studies on the non-Hodgin's lymphoma treatment, Bexxar.
The FDA, in a review letter, told Corixa its response to an earlier review letter didn't provide sufficient safety and net clinical benefit evidence.
In a press release Wednesday, Corixa said it is extremely disappointed with the FDA's decision and intends to promptly pursue resolution with the FDA and GlaxoSmithKline PLC (GSK), which is the co-developer of Bexxar in the U.S.
Corixa is formally requesting a meeting with the FDA and hopes to reach mutual agreement on the specific steps needed for Bexxar's approval. The company plans to provide additional guidance to Bexxar's regulatory pathway after further discussions with GlaxoSmithKline and the FDA.
Company Web site: corixa.com
Corixa said the FDA stated the data reviewed by the agency doesn't provide sufficient evidence that Bexxar addresses an unmet medical need. The findings affects the company's prior request for accelerated approval on Bexxar.
The immunotherapeutics developer is required to respond to the latest FDA review letter within 10 days of receipt, which occurred Tuesday.
The company must either amend the application, notify the agency of its intent to file an amendment, withdraw the application or request a hearing on whether there are grounds for denying the application's an approval.
Corixa, which formally requested a meeting, expects to meet with FDA representatives within 45 days.
In March 2001, The FDA sent Corixa and GlaxoSmithKline a complete review letter concerning Bexxar's Biologics License Application. The agency outlined additional clinical and manufacturing information Corixa needed to submit. The FDA also requested updated and/or final safety and efficacy data from trials.
Three months later, Corixa said it was making "excellent progress" on completing its response to questions the FDA raised on Bexxar's Biologics License Application. Corixa and GlaxoSmithKline submitted data on Bexxar to the FDA in August and filed final responses to the FDA's request for more information in September. |
