[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
January NaN, 2014

The Accelerated Approval of Oncologic DrugsLessons From Ponatinib

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

First Page Preview View Large
First page PDF preview
First page PDF preview