FDA approves Takeda's ICLUSIG (ponatinib) treatment for drug-resistant or drug-resistant chronic granulocytic leukemia

Chronic granulocytic leukemia (CML) accounts for 15% of all leukemia patients.
leukemia is manifested in the uncontrolled growth of primary granulocytes in the body's bone marrow and their accumulation in the blood.
. Takeda Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved ICUSIG® (ponatinib) to treat patients with chronic granulocytic leukemia (CML) who are resistant to kinase inhibitors or are resistant to drugs.
FDA approval is an important milestone in the CML," said Teresa Bitetti, president of Global Oncology at Takeda.
that although CML is usually manageable, the long-term prognostication of many patients is still poor.
ICUSIG has been shown to be effective in many drug-resistant patients, and using ICUSIG at critical moments can lead to meaningful results for these patients."
approval is based on data from the Phase II OPTIC trial and five-year data from the Phase II PACE trial.
in the OPTIC trial, 42% of patients reached BTIC-ABL1IS≤1% (optic's primary endpoint) at 12 months, with a medium follow-up time of 28.5 months and 73% still responding to treatment.
13 per cent of these patients experienced any grade AE, and 7 per cent experienced a grade 3 or higher AE.
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