Corixa [CRXA] - cancer vaccines Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Corixa [CRXA] - cancer vaccines

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: Andreas Helke who started this subject	12/14/2002 1:21:43 AM
From: sim1	Read Replies (1) of 222

GSK/Corixa Likely To Emphasize Bexxar’s Durability Of Response At Cmte. Meeting GlaxoSmithKline and Corixa will likely highlight a 14.7-month duration of response for Bexxar in patients with relapse or refractory low grade non-Hodgkin’s lymphoma in its presentation before FDA’s Oncologic Drugs Advisory Committee on Dec. 17. Long-term data that the companies have collected from a follow-up of 250 patients in five trials show an overall response rate of 56% for Bexxar. Among patients who experienced a complete response during the trials, the survival rate is 70% with a median CR duration of over 7.8 years. GSK and Corixa hope the data analysis will support a recommendation for approval of Bexxar (tositumomab and iodine I 131 tositumomab) without requiring additional data. FDA concluded that more data would be necessary for approval in a March 12 "complete review" letter for the BLA. Corixa and GSK appealed the FDA action requesting a committee review and submitted the new data analysis to FDA in October. Recently, the companies said that FDA has accepted the October submission as a complete response to issues raised in its complete review letter. The agency is treating the submission as substantial new information which will require an extension of the user fee review deadline for Bexxar to May 2, 2003. It is the second time that Corixa has submitted more information in response to a complete review letter for Bexxar. FDA wrote the company in March 2001 requesting more safety and efficacy data from ongoing studies. GSK and Corixa had predicted a committee review that year. Corixa is seeking an indication for Bexxar for the treatment of patients with relapsed or refractory low-grade follicular or transformed low-grade B-cell non-Hodgkin’s lymphoma, including patients with rituximab-refractory follicular non-Hodgkin’s lymphoma.<snip> Posted: Friday, December 13, 2002 fdaadvisorycommittee.com

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next