The Accelerated Approval of Oncologic Drugs Lessons From Ponatinib

• Autores: Vinay Prasad, Sham Mailankody
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 311, Nº. 4, 2014, págs. 353-354
• Idioma: inglés
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• Resumen

  • 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).