米食品医薬品局(FDA)がIDH1遺伝子変異陽性の再発/治療抵抗性急性骨髄性白血病に対する初のIDH1阻害薬としてivosidenibを承認【FDA】

同時にIDH1遺伝子変異を検出するコンパニオン診断薬も承認

 FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

 

 

 

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