Genentech and Biogen Idec are crowing today about Rituxan's performance in a leukemia trial. The late-stage research found that Rituxan in combo with two chemo drugs "significantly" boosted progression-free survival for patients who had relapsed with chronic lymphocytic leukemia. The trial data is now under independent review, the companies said, "for U.S. regulatory purposes."
In other words, expect an application for broader Rituxan use. "We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future," Genentech's SVP Dr. Hal Barron said in a statement.
Rituxan is now approved to combat rheumatoid arthritis [1] and non-Hodgkins' lymphoma. Earlier this year, another late-stage study found that a similar Rituxan combo improved progression-free survival in leukemia patients who hadn't been previously treated. So the companies have promising data in both untreated patients and relapsed patients. We'll keep our eyes open for FDA action [2].
- read the joint release
[3]- see the Associated Press article [4]
Related Articles:
Rituxan fails (again) in late-stage lupus trial [5]
Rituxan patient dies from PML [6]
Will Rituxan be next MS breakthrough? [7]
Genentech and Biogen Idec in talks over Rituxan [8] (Aug. 2006)
Links:
[1] http://www.fiercebiotech.com/story/fda-approves-rituxan-for-rheumatoid-arthritis/2006-03-01
[2] http://www.fiercepharma.com/special-reports/september-fda-news-review
[3] http://www.fiercebiotech.com/press-releases/phase-iii-study-showed-rituxan-combination-chemotherapy-improved-progression-free-sur
[4] http://biz.yahoo.com/ap/081007/genentech_rituxan.html?.v=1
[5] http://www.fiercebiotech.com/story/rituxan-fails-again-in-late-stage-lupus-trial/2008-04-29
[6] http://www.fiercepharma.com/story/rituxan-patient-dies-pml/2008-09-12
[7] http://www.fiercepharma.com/story/spotlight-will-rituxan-be-next-ms-breakthrough/2008-02-14
[8] http://www.fiercebiotech.com/story/genentech-and-biogen-idec-in-talks-over-rituxan/2006-08-04