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相关临床试验
1
0 进行中
药物批准
56
批准总数
监管机构
监管机构数
成立时间
1998
招募中
100.0%
FDA
Food and Drug Administration
- The FDA has approved nilotinib tablets (Danziten) for Philadelphia chromosome-positive chronic myeloid leukemia (CML) patients, offering a new treatment option. - Danziten eliminates the need for fasting, unlike the original nilotinib formulation (Tasigna), which required strict mealtime restrictions to avoid cardiotoxicity. - The approval includes newly diagnosed CML patients and those with resistance or intolerance to prior therapy, including imatinib. - This new formulation provides equivalent efficacy to Tasigna but without the boxed warning requirement for fasted-state administration, improving patient convenience.
