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.
LIST OF FIGURES
12 Figure 1: Iclusig for CML – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Iclusig for CML
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Iclusig for CML
21 Figure 4: Iclusig – SWOT analysis in acute lymphoblastic leukemia
22 Figure 5: Datamonitor Healthcare’s drug assessment summary for Iclusig in acute lymphoblastic leukemia
23 Figure 6: Datamonitor Healthcare’s drug assessment summary for Iclusig in acute lymphoblastic leukemia
LIST OF TABLES
5 Table 1: Iclusig drug profile
7 Table 2: Iclusig pivotal trial data in CML
10 Table 3: Iclusig late-phase trial data in CML
11 Table 4: Iclusig ongoing late-phase clinical trials in CML
19 Table 5: Iclusig drug profile
20 Table 6: Pivotal clinical trial data for Iclusig in acute lymphoblastic leukemia
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