24month follow up from the PACE trial serves to remind patients currently being treated with the full dose (45mg) of ponatinib to speak to your clinicians if you are at all worried or have any concerns about signs or possible symptoms of any cardiovascular problems
Sandy.
Ariad shares plunge after it pauses enrollment for leukemia drug trial •
Ariad Pharmaceuticals (ARIA) collapses 59% after the company says that it's suspending the enrollment of new patients in trials for its Iclusig treatment for chronic myeloid leukemia.
The pause follows an increase in the rate of cardiac problems in patients who received Iclusig.
Pending FDA approval, Ariad hopes to resume enrollment with lower doses of the drug. Patients already on the medicine will continue to do so but with smaller doses.
The U.S. prescribing information for Iclusig remains unchanged. (PR)
See home page to access press release from ARIAD
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"The shock US FDA hold slapped today on studies of Ariad Pharmaceuticals' (ARIA) leukemia drug Iclusig serves as a timely reminder to sellside analysts of the high risk associated even with advanced projects, let alone those in early development.
Cardiac problems
Still, the warning signs were there. Indeed, at the time of approval the FDA called for a black box warning of arterial thrombosis and liver toxicity seen in ponatinib's Pace trial, and rumbling fears caused Ariad's stock to lose 32% since its October 2012 peak even before today's unpleasant setback.
The FDA hold was announced after both the US and European agencies conducted a risk analysis of ongoing studies, in particular the Pace trial. After 24 months follow-up in Pace, cardiac problems with Iclusig have not only continued, but they have increased.
Serious arterial thrombosis occurred in 11.8% of Iclusig-treated patients - up from the 8.0% after 11 months reflected in current prescribing information - while serious venous occlusion rose from 2.2% to 2.9%.
As such, Ariad said it would stop enrollment into all studies, though it went to some lengths to stress that it viewed the FDA hold as "temporary." Clinicaltrials.gov lists 12 active studies, 10 of which are actively recruiting.
Right now Ariad's only hope seems to be to modify trials, reducing the Iclusig dose to cut adverse events and hope that a sufficient therapeutic window remains. It claims to have evidence of continued efficacy at lower doses, and insists that the first-line indication is still worth investing in....."
full article here:
http://seekingalpha.com/article/1737272-ariads-nasty-surprise-gives-the-...