FDA approval to addition of OS Data in labelling of Gilteritinib


The US Food and Drug Administration has approved the addition of overall survival (OS) data in labelling process of Gilteritinib, a cancer drug which was indicated for adult patients who had relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. FLT3 is a receptor tyrosine kinase with important roles in cell survival and proliferation. It is mutated in one -third of AML patients. Gliteritinib acts as an inhibitor of AXL receptor tyrosine kinase, an enzyme in humans encoded by AXL gene . The AXL gene plays a crucial role in facilitating immune escape and drug resistance by cancer cell, leading to metastatic cancers.  

According to results, treatment with the FLT3-targeted therapeutic Gilteritinib has shown improved survival for patients with relapsed or refractory acute myeloid leukemia harbouring an FLT3 mutation compared with standard chemotherapy regiments.

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