Drug analysis: Iclusig

  • ID: 4462158
  • Drug Pipelines
  • 25 pages
  • Datamonitor Healthcare
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Drug Overview

Iclusig (ponatinib; Takeda/Incyte/Otsuka) is a BCR-ABL tyrosine kinase inhibitor (TKI). Preclinical studies have also shown selective inhibition of other tyrosine kinases, including FLT3, RET, KIT, and the members of the fibroblast growth factor receptor, platelet-derived growth factor receptor, and vascular endothelial growth factor receptor families of kinases. Iclusig demonstrated inhibition of wild-type and mutated forms of BCR-ABL, including T315I, the highly drug-resistant missense mutation of BCR-ABL. In mice, treatment with Iclusig reduced the size of tumors expressing native or T315I-mutant BCR-ABL when compared to controls.

After a brief suspension due to an increased risk of arterial thrombosis, Ariad reinstated Iclusig’s commercialization for patients with refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia in January 2014. This event was contingent upon US Food and Drug Administration (FDA) requirements that safety measures, additional product labeling, a Risk Evaluation and Mitigation Strategy, and post-marketing investigations be put in place prior to marketing and commercialization.
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Product Profiles
Iclusig: Chronic myeloid leukemia (CML)
Iclusig: Acute lymphoblastic leukemia (ALL)

List of Figures
Figure 1: Iclusig for CML - SWOT analysis
Figure 2: Drug assessment summary of Iclusig for CML
Figure 3: Drug assessment summary of Iclusig for CML
Figure 4: Iclusig - SWOT analysis in acute lymphoblastic leukemia
Figure 5: Drug assessment summary for Iclusig in acute lymphoblastic leukemia
Figure 6: Drug assessment summary for Iclusig in acute lymphoblastic leukemia

List of Tables
Table 1: Iclusig drug profile
Table 2: Iclusig pivotal trial data in CML
Table 3: Iclusig late-phase trial data in CML
Table 4: Iclusig ongoing late-phase clinical trials in CML
Table 5: Iclusig drug profile
Table 6: Pivotal clinical trial data for Iclusig in acute lymphoblastic leukemia
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