Sales of Blood Cancer Drug Ponatinib (Iclusig) Suspended
Company responds to FDA request (October 31)
Ariad Pharmaceuticals has agreed to an FDA request that the company suspend marketing and sales of ponatinib (Iclusig) because of the risk of life-threatening blood clots and severe narrowing of blood vessels. The agency will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks.
At this time, health care professionals should follow the FDA’s new recommendations for the drug:
- Patients who are not responding to ponatinib should immediately discontinue treatment and discuss alternative treatment options with their health care professionals.
- Patients who are currently taking ponatinib and are responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded-access registry program while the FDA’s safety investigation continues.
- Health care professionals should not start treating new patients with ponatinib unless no other treatment options are available and all other available therapies have failed.
The FDA’s recent investigation of ponatinib revealed an increased frequency of blood clots and narrowing of blood vessels since the drug was approved in December 2012. Approximately 24% of patients in a phase II clinical trial (median treatment duration, 1.3 years) and approximately 48% of patients in a phase I trial (median treatment duration, 2.7 years) experienced serious adverse vascular events, including fatal and life-threatening heart attacks, strokes, 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.
Source: FDA; October 31, 2013.