PARIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that the marketing authorization application for PYLCLARI® (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) submitted by exclusive Swiss distributor b.e.imaging AG on 31 January 2024 to the Swiss Agency for Therapeutic Products (Swissmedic) has been accepted for evaluation.

2024年2月22日，巴黎（环球通讯社）--世界核医学领导者库里姆今天宣布，瑞士独家经销商b.e.imaging AG于2024年1月31日提交给瑞士治疗产品管理局（Swissmedic）的PYLCLARI®（INN:Piflufolastat（18F），原名（18F）-DCFPyL）的上市授权申请已被接受评估。

PYLCLARI® is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to initial curative therapyTo localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for around 23 percent of all new cancer cases in 2020 and nearly 10 percent of all deaths due to cancer in men.

PYLCLARI®适用于用正电子发射断层扫描（PET）检测成人前列腺癌（PCa）中前列腺特异性膜抗原（PSMA）阳性病变在以下临床情况下：在初始治愈性治疗之前对高危PCa患者进行初步分期，根据治愈性意向初次治疗后血清前列腺特异性抗原（PSA）水平升高，将疑似复发患者的PCa复发定位前列腺癌是欧洲男性中最常被诊断出的癌症之一，2020年，约占所有新发癌症病例的23%，占男性癌症死亡人数的近10%。

Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule. We are fully dedicated to improving the situation of prostate cancer patients in Switzerland.” Benoit Woessmer, PET Europe CEO at Curium, commented, “The acceptance of the marketing authorization application by Swissmedic for PYLCLARI® is another important milestone for prostate cancer patients in Switzerland.

b.e.imaging放射性药物主管Michel Wuillemin博士评论道：“b.e.imaging为提前向Swissmedic提交PYLCLARI®的上市授权申请感到骄傲。我们全力致力于改善瑞士前列腺癌患者的状况。”Curium PET欧洲首席执行官Benoit Woessmer评论道，“Swissmedic接受PYLCLARI®的上市授权申请是瑞士前列腺癌患者的另一个重要里程碑。

We look forward to providing an improved choice of tools available to physicians for the diagnosis of prostate cancer patients. Importantly, when in full production PYLCLARI® is expected to be the most widely ava.

我们期待着为医生提供更好的工具选择，用于诊断前列腺癌患者。重要的是，在全面生产时，PYLCLARI®有望成为最广泛的ava。