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January 22/29, 2014

The Accelerated Approval of Oncologic Drugs: Lessons From Ponatinib

Author Affiliations
  • 1Medical Oncology Service, National Cancer Institute, Bethesda, Maryland
 

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(4):353-354. doi:10.1001/jama.2013.284531

On October 31, 2013, the US Food and Drug Administration (FDA) suspended marketing and sales of the BCR-ABL tyrosine kinase inhibitor ponatinib (Iclusig, Ariad Pharmaceuticals). Just 7 weeks later, on December 20, 2013, the FDA partially reversed that decision, permitting use of the drug under a narrower indication. Ponatinib was the sixth drug approved for the treatment of chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia and indicated for patients refractory or intolerant to prior tyrosine kinase inhibitor (TKI) therapy (Table).

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