米食品医薬品局(FDA)がCDK4/6阻害薬ribociclibのアロマターゼ阻害薬との併用投与について、新たな審査法を用いてHR陽性HER2陰性の進行乳がんの閉経前および閉経期前後の女性に対する適応拡大を承認【FDA】

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved Kisqali in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

 


 


 

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