FDA Suspends Marketing and Sales of Iclusig Pending Investigation

In a bit of breaking news last night, the FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of its chemotherapy drug Iclusig (ponatinib) until further notice.

Iclusig is used to treat chronic myeloid leukemia.

On Oct. 11, the FDA asked that Ariad halt all clinical trials of the drug due to blood clots.

Last night, the agency went a big step further.

Agency calls for discontinued use

First the agency said that any patients currently receiving Iclusig but not responding should discontinue it immediately.

Any patients who are responding to it and whose physicians believe that the benefits outweigh the risks need to be treated under a single-patient Investigational New Drug (IND) application, or under an expanded access registry program, for the time being.

Finally, unless there are simply no options left, healthcare professionals should not start anyone on the drug for the time being.

Severe side effects

According to the FDA, about one-quarter of patients in a phase II trial of the drug – and almost half of those in a phase I trial – experienced adverse side effects. The FDA stated:

[These patients] have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow.

The FDA has launched an investigation, and until it reaches a conclusion, Iclusig has been ground to a halt.

Source: FDA