http://www.clinicalt...how/NCT01592136

Expanded Access Program of Ponatinib
#1
Posted 08 May 2012 - 11:58 AM
#2
Posted 10 May 2012 - 05:04 PM
This may have been posted earlier but I had not seen it.
It has been reported that ARIAD may skip Phase 3 trials and go to the FDA this fall for approval.
from Boston.com 2/15/12
Ariad expects to file a new drug application next fall for ponatinib, which was discovered by scientists at the company's labs over the past decade.
The Food and Drug Administration would then decide early next year whether to approve it for CML patients who have been failed by multiple other treatments and have no other treatment options.
After that, Ariad would seek approval to use the drug for newly diagnosed CML patients.
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