Iclusig Leukemia Drug: Reports of Deaths and Serious Injury
Reports of over a dozen deaths and serious injury to others from “fast track approval” drug Iclusig has prompted Ariad pharmaceutical to suspend all sales, marketing and clinical trials of the drug immediately. The drug was approved last December to treat two types of cancer, for patients who do not respond to other therapies.
Patients prescribed the drug and others in post-approval clinical trials are reporting adverse events, in some cases as soon as two weeks after starting the drug according to Medscape.
As reported by Law360:
The dramatic development came three weeks after FDA began investigating vascular side effects and was apparently spurred by eye-popping rates of adverse events among participants in trials being conducted after the chemotherapy drug won accelerated approval in December to treat two rare blood cancers.
An FDA spokeswoman told Law360 that preliminary data indicate at least 14 deaths have occurred among 530 total patients in a pair of Iclusig studies. The fatalities were all linked to “cardiac, cerebrovascular or peripheral vascular causes,” according to the FDA official.
Readers of my blog may remember our firm’s representation of patients injured in clinical trials, now settled confidentially.
“Clinical Trial Deaths Lead Ariad to Halt Iclusig Sales” Law360, October 31, 2013 (subscription required)
“Leukemia Drug Iclusig Pulled From Market” Medscape, October 31, 2013
“Ariad Suspends Sales of Cancer Pill Iclusig” AP and ABC News, October 31, 2013