Expanded Treatment Options for Chronic Myeloid Leukemia... MFDS Approves Pfizer's 'Bosulif'
[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety announced on the 13th that it approved three dosages (100, 400, 500 mg) of Bosulif tablets (Bosutinib), a treatment for Philadelphia chromosome-positive chronic myeloid leukemia (CML) by Korea Pfizer Inc., on the 12th.
The Philadelphia chromosome refers to a chromosome formed by the reciprocal translocation of parts of chromosomes 9 and 22. CML, a blood cancer characterized by excessive proliferation of abnormal blood cells and a very slow progression, is known to be caused mostly by the Philadelphia chromosome.
Bosulif tablets work by inhibiting the expression of abnormal proteins activated by the Philadelphia chromosome, thereby preventing the excessive proliferation of abnormal blood cells. It was previously approved by the U.S. Food and Drug Administration (FDA) in 2017 and the European Medicines Agency (EMA) in 2018.
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The indications are adult patients newly diagnosed with chronic-phase Philadelphia chromosome-positive CML, and adult patients with chronic, accelerated, or blast phases of Philadelphia chromosome-positive CML who show resistance or intolerance to prior therapies.
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