The FDA has asked ARIAD Pharmaceuticals to suspend the marketing and sales of Iclusig (ponatinib) due to the risk of life-threatening blood clots and severe narrowing of blood vessels.
Earlier this month, the FDA had released a safety alert regarding reports of serious and possibly fatal blood clots in patients taking Iclusig.
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Iclusig is a kinase inhibitor indicated for chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, and for Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
The FDA has recommended the following for patients and healthcare professionals during this time of evaluation:
- Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment and discuss alternative treatment options
- Patients currently taking Iclusig and 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. Upon the determination of their health care professional, these patients can be considered for treatment under an IND or expanded access registry program.
The FDA will continue to notify healthcare professionals and patients as more information becomes available.
For more information call (888) 463-6332 or visit the FDA Safety Alerts page.