FDA授予前列腺癌PET显像剂64Cu-SAR-bisPSMA突破性疗法认定：复发病灶检出率78%对36%
澳大利亚 Sydney 的临床期放射性药物公司 Clarity Pharmaceuticals 11月12日宣布，美国食品药品监管局 FDA 已授予其显像剂 64Cu-SAR-bisPSMA 突破性疗法认定，用于对前列腺特异性膜抗原（PSMA）阳性病灶做正电子发射断层扫描（PET），对象是前列腺癌根治术后血清 PSA 升高、怀疑生化复发的男性患者。这是 PSMA PET 显像领域有史以来第一个突破性疗法认定。
突破性疗法认定是 FDA 为治疗严重疾病、且初步临床证据显示可能比现有疗法有实质改进的药物设立的加速通道，获认定后可得到 FDA 的密集指导与协同审评。此次认定依据三部分证据：二期 Co-PSMA 试验、一期/二期 COBRA 试验，以及真实世界证据，三者都显示该显像剂对复发病灶的诊断表现优于现行标准 PSMA PET。
Co-PSMA 试验在根治性前列腺切除术后生化复发的50名患者中，把 64Cu-SAR-bisPSMA 与现行标准显像剂 68Ga-PSMA-11 头对头比较：阳性检出率为78%对36%，检出的病灶总数为63个对24个，人均病灶数1.26个对0.48个，真阳性率71%对29%。该显像剂此前已两次获得 FDA 快速通道认定。
Clarity 目前正推进两项注册性三期试验 AMPLIFY 与 CLARIFY，均已完成受试者入组、正在随访期，预计2027年上半年公布顶线数据，用以支持向 FDA 提交上市申请。公司执行主席 Alan Taylor 表示，FDA 授予 PSMA PET 显像史上第一个突破性疗法认定，凸显了更准确检出前列腺癌复发病灶这一尚未满足的需求，也说明现有数据的分量。
据美国癌症协会估计，2026年美国约有333,830例新发前列腺癌病例、约36,320人死于该病。需要说明的是，突破性疗法认定不是上市批准，该显像剂能否最终获批，仍取决于三期试验结果与 FDA 的完整审评。
FDA Grants Breakthrough Therapy Designation to 64Cu-SAR-bisPSMA for Prostate Cancer PET Imaging: 78% Detection vs 36% in Trial
Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company based in Sydney, Australia, announced on November 12 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its imaging agent 64Cu-SAR-bisPSMA for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum PSA levels after definitive treatment. It is the first Breakthrough Therapy designation ever granted in PSMA PET imaging.
Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs intended to treat a serious condition where preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapy, and it brings intensive FDA guidance and a collaborative review process. The designation was supported by data from the Phase II Co-PSMA trial, the Phase I/II COBRA trial and real-world evidence, which collectively indicate enhanced diagnostic performance of 64Cu-SAR-bisPSMA over standard-of-care PSMA PET in patients with biochemical recurrence of prostate cancer.
In the Co-PSMA trial, 64Cu-SAR-bisPSMA was compared head-to-head with the standard agent 68Ga-PSMA-11 in 50 patients with biochemical recurrence after radical prostatectomy: the proportion of participants with a positive scan was 78% versus 36%, total lesions detected were 63 versus 24, the mean number of lesions per participant was 1.26 versus 0.48, and the true positive rate was 71% versus 29%. The agent had previously received two FDA Fast Track designations.
Clarity is progressing two registrational Phase III trials, AMPLIFY and CLARIFY, both of which have completed recruitment and are in patient follow-up. Topline data from both trials are anticipated in the first half of 2027 and are intended to support an FDA application for approval. Executive Chairperson Alan Taylor said the FDA's award of the first Breakthrough Therapy designation in the history of PSMA PET imaging highlights both the unmet need for more accurate detection of recurrent prostate cancer lesions and the significance of the data generated to date.
The American Cancer Society estimates about 333,830 new cases of prostate cancer in the United States in 2026 and around 36,320 deaths from the disease. A Breakthrough Therapy designation is not a marketing approval: whether the agent is ultimately approved will depend on the Phase III results and the FDA's full review.
来源：Clarity Pharmaceuticals
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监管局 FDA 总部。编辑部联邦固定图库。 / Image: U.S. Food and Drug Administration headquarters. GSM federal asset library.
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