米食品医薬品局(FDA)が、抗CTLA-4抗体イピリムマブについて、マイクロサテライト不安定性が高い(MSI-H)またはミスマッチ修復機構の欠損 (dMMR)を有する進行大腸がんに対する適応を迅速承認【FDA】

FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer


On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

 


 


 

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