Sales of leukemia chemotherapy drug suspended

November 5, 2013
Mark Lowery, Editor
Mark Lowery, Editor

Mark Lowery an Editor for Drug Topics magazine.

Citing the risk of life-threatening blood clots and severe narrowing of blood vessels, FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of ponatinib (Iclusig).

Citing the risk of life-threatening blood clots and severe narrowing of blood vessels, FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of ponatinib (Iclusig).

Ariad has agreed to FDA’s request, and the agency is advising patients receiving ponatinib to speak with their physicians to discuss the risks and benefits of continuing to use the drug.

“We 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,” a FDA spokesperson said.

According to an FDA investigation, approximately 24% of patients in the phase 2 clinical trial and approximately 48% of patients in the phase 1 clinical trial 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.

FDA said it couldn’t identify a dose level or exposure duration for ponatinib that is safe.

FDA officials said patients who are currently taking ponatinib and responding to the drug, and whose healthcare 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 FDA’s safety investigation continues.

However, FDA said healthcare professionals should not start treating new patients with ponatinib unless no other treatment options are available and all other available therapies have failed.