2021-05-27,美国食品药品监督管理局(FDA)正式批准美国Lantheus公司的Piflufolastat F 18注射液(18 F标记的诊断显像剂,商品名:PYLARIFY®)用于前列腺癌患者前列腺特异性膜抗原(PSMA)阳性病变的正电子发射型计算机断层显像(PET),以便更加准确地识别前列腺癌的疑似转移或复发.Piflufolastat F 18被FDA批准用于2种适应证:第1个是对首诊疑似前列腺癌患者的初步分期;第2个是鉴别前列腺癌生化复发患者病灶的再分期.
Piflufolastat F 18 for PSMA PET imaging in prostate cancer
On May 27,2021,the U.S.Food and Drug Administration(FDA)officially approved Lantheus'PYLARIFY®(Piflufolastat F 18,18 F-labeled imaging agent),which can be used for positron emission computed tomography(PET)of prostate-specific membrane antigen(PSMA)-positive lesions in prostate cancer patients to accurately identify prostate cancer with suspected metastasis or recurrence.Piflufolastat F 18 is approved by FDA for two indications.The first is the initial staging for suspected metastatic lesions in men with newly diagnosed prostate cancer.The second is restaging,with the goal of identifying lesions in the setting of biochem ical recurrence.
Piflufolastat F 18prostate cancerprostate specific membrane antigenpositron emission computed tomography
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