The FDA is requiring new safety measures for Iclusig (ponatinib; ARIAD) to address the risk of possibly fatal blood clots and severe narrowing of blood vessels.
Marketing of Iclusig is expected to resume after these new safety measures are implemented by the end of January 2014.
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On October 31, 2013, ARIAD agreed to voluntarily suspend marketing of Iclusig after an FDA investigation showed a steady increase in the number of serious vascular occlusion events identified through continued safety monitoring of Iclusig.
The new required safety measures include:
- Narrowing of the indication to state: “Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.”
- Revising Warnings & Precautions to describe the vascular occlusion events
- Revising Dosage & Administration to state that the optimal dose has not been identified, as well as including additional information regarding dose decreases and discontinuations
- Revising the patient Medication Guide to include additional safety information consistent with the revised drug label
- A required REMS to inform prescribers about the approved indications for use and the serious risk of vascular occlusion and thromboembolism
- Post-market investigations to further evaluate dose selection, drug exposure, treatment response and toxicity of Iclusig therapy
Patients should continue to receive Iclusig under their authorized emergency investigational new drug applications (INDs) until marketing of Iclusig is resumed.
Once the process is complete, patients being treated under these INDs can begin receiving the marketed Iclusig product.
For more information call (800) 332-1088 or visit the FDA Safety Report.