FDA grants supplemental approval for Iclusig in CP chronic myeloid leukemia.- Takeda

Takeda Pharmaceutical Co announced that the FDA has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for adult patients with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. The updated label includes an optimized, response-based Iclusig dosing regimen in CP-CML with a daily starting dose of 45 mg and, upon achieving =<1% bcr-abl1is dose reduction to 15 mg. this dosing regimen aims to maximize benefit-risk by providing efficacy and decreasing the risk of adverse events aes including arterial occlusive events aoes. the snda approval is based on data from the phase ii optic optimizing ponatinib treatment in cml trial as well as five-year data from the phase ii pace ponatinib ph all and cml evaluation trial. the optic trial included patients with cp-cml whose disease was highly-resistant to their immediate prior tki the majority of whom 65 did not achieve a response greater than complete hematological response chr on immediate prior therapy. at 12 months 42 of 88 patients utilizing the newly approved response-based dosing regimen 45 mg to 15 mg achieved less than bcr-abl1is the primary endpoint of optic and at a median follow up time of 28.5 months 73 of these patients maintained their response. in these patients 13 experienced an aoe of any grade 7 experienced grade 3 or higher. risk factors such as uncontrolled hypertension or diabetes should be managed and caution should be exercised when treating patients with active or substantial history of clinically significant uncontrolled cardiovascular disease.>