Friday, November 01, 2013

FDA Asks Ariad to Halt Sale of Leukemia Drug Iclusig

The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of "life-threatening blood clots and severe narrowing of blood vessels".
  • Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
  • Patients who are currently taking Iclusig, who are 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.
  • Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.