2016年5月27日,美国食品和药品监管局(FDA)批准Axumin([F-18] Fluciclovine)，一个放射性诊断剂注射液。Axumin是根据以前治疗后升高的前列腺抗原抗原(PSA)水平对正电子发射断层扫描(PET)影像适用有怀疑前列腺癌复发男性。
前列腺癌在美国男性是癌症死亡的第二主要原因。在有原发性治疗后患者有怀疑的癌复发，准确分期是提高处置水平和结局的一个重要目标。
FDA的药品评价和研究中心医学影像产品部主任Libero Marzella，M.D.，Ph.D.说：“当PSA处在非常低水平时，影像测试不能确定复发前列腺癌的位置，”。“对这些患者Axumin是提供显示另一个准确影像的方法。”
两项研究对在有复发疾病患者中前列腺癌影像评价Axumin的安全性和疗效。第一项在在有怀疑的复发前列腺癌男性比较Axumin通过前列腺活检得到对组织病理学扫描(研究疾病所致组织变化)105次和通过怀疑影像的病变的活检准确分期是提高管理水平和成果的一个重要目标。放射科医生初始现场阅读扫描；随后地，三名独立的放射科医生在盲态阅读相同扫描研究。
第二项研究评价96 Axumin和C11胆碱(一个被批准的PET扫描影像测试)扫描间一致性在患者有中位PSA值1.44 ng/mL。放射科医生现场阅读扫描，和相同在第一项研究的三例独立的放射科医生阅读扫描研究在第二项盲态研究阅读Axumin扫描。独立扫描读数的结果是一般地彼此互相一致，而且确证现场扫描读数的结果。两项研究支持以前治疗后有升高的PSA水平男性中Axumin对前列腺癌影像的安全性和疗效。
Axumin是一种放射性药物和应用适当安全性措施处置以缩小给药期间对患者和卫生保健提供者暴露。用Axumin PET影像可能发生影像解释误差。不能除外复发前列腺癌存在一个阴性(负性)影像和一个阳性影像不能确证复发前列腺癌的存在。建议临床相关，它可能包括怀疑的复发部位的组织病理学评价。
在患者中最常报道的不良反应是注射部位疼痛，发红，和在口中一种金属味。
Axumin是由联合王国牛津Blue Earth Diagnostics，Ltd公司上市。
Axumin([F-18] Fluciclovine)
FDA approved the radioactive diagnostic agent fluciclovine (F-18, Axumin) for use with positron emission tomography (PET) to detect recurrent prostate cancer.
A synthetic amino acid, F-18 received approval for use to confirm suspected recurrence in men with treated prostate cancer and rising PSA levels.
Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels," Libero Marzella, MD, PhD, director of the FDA's Division of Medical Imaging Products, said in a statement. "Axumin is shown to provide another accurate imaging approach for these patients."
The safety and efficacy of F-18 was eva luated in two trials involving men with treated prostate cancer and elevated PSA levels (biochemical recurrence or relapse). In one study, investigators on site compared F-18 imaging results with pathology findings for 105 men. Independent radiologists then performed the same comparison.
In the second study, radiologists eva luated agreement between F-18 imaging results and those obtained with C-11 choline, another FDA-approved imaging agent approved for use with PET. The study involved 96 men with treated prostate cancer and a median PSA level of 1.44 ng/mL.
Results with both imaging modalities were eva luated on site by radiologists and by independent radiologists blinded to the on-site results. According to the FDA, independent assessment showed the results with the two imaging agents "were generally consistent with one another" and confirmed the on-site assessments.
The most commonly reported adverse events were injection-site pain, redness, and a metallic taste in patients who receive injections of the radioactive agent.
The FDA statement noted that imaging errors can occur with F-18 and that a negative result does not rule out the possibility of prostate cancer recurrence and that positive tests can occur in the absence of prostate cancer.
F-18 is marketed by Blue Earth Diagnostics of Oxford, England. |
