The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig (ponatinib) is on track to obtain priority review status for the treatment of specific leukemia conditions in China. These include chronic myeloid leukemia (CML) that is resistant or intolerant to previous medications, recurrent or refractory Philadelphia chromosome-positive acute lymphocytic leukemia (ALL), T315I positive chronic myeloid leukemia, and T315I positive Philadelphia chromosome-positive acute lymphocytic leukemia.
Iclusig’s Third-Generation TKI and US Approval History
Iclusig, a third-generation tyrosine kinase inhibitor (TKI), was fast-tracked in the US in December 2012 for use in chronic myeloid leukemia (CML) with ABL T315I mutation or acute lymphocytic leukemia (ALL) with Philadelphia chromosome-positive (Ph+), or CML or ALL with resistance or intolerance to previous TKIs. The drug received full approval in the US in 2016. In December 2020, Iclusig was approved to treat chronic CML with resistance or intolerance to at least two previous kinase inhibitors, marking a significant expansion of its indications.
Implications for Chinese Market
The anticipated priority review status by the CDE in China suggests that Iclusig may soon play a crucial role in the treatment of leukemia in the country. This development could provide an additional therapeutic option for patients with leukemia who have limited treatment options due to resistance or intolerance to existing medications.-Fineline Info & Tech
