The Theranostic PSMA Ligand PSMA-617 in the Diagnosis of Prostate Cancer by PET/CT: Biodistribution in Humans, Radiation Dosimetry, and First Evaluation of Tumor Lesions.

2021年6月29日 · The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose tumors overproduce the PSMA protein. Their cancer …

2021年6月23日 · Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer. Lutetium-177 (177 Lu)–PSMA-617 is a radioligand therapy that delivers...

2025年3月28日 · 177Lu-PSMA-617 is now approved for PSMA-positive mCRPC patients post-ARPI therapy, delaying taxane-based chemotherapy. The phase 3 PSMAfore trial showed a 59% reduction in radiographic progression or death risk with 177Lu-PSMA-617. Median radiographic progression-free survival was 11.6 months with ...

2025年3月28日 · What this means for patients: Today, the therapy 177lutetium-PSMA-617 (Lu-PSMA; trade name Pluvicto®) was approved by the FDA for patients with advanced (metastatic) prostate cancer who have been treated with androgen receptor pathway inhibitor therapy. This medicine delivers a small dose of radiation attached to a molecule that specifically binds to …

2025年4月9日 · Zachary Klaassen speaks with Oliver Sartor about the FDA's expanded approval of Pluvicto™ (177Lu-PSMA-617) for metastatic castration-resistant prostate cancer patients in the taxane-naive setting. Dr. Sartor discusses the PSMAfore trial that led to this expansion, which showed a 59% reduction in progression risk compared to alternative ARPI therapy. This …

On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto).

2025年2月13日 · The randomised phase 2 ENZA-p trial compared standard-of-care enzalutamide versus enzalutamide plus adaptive-dosed [177 Lu]Lu-PSMA-617 in participants with metastatic castration-resistant prostate cancer with prostate-specific antigen (PSA) progression-free survival as the primary endpoint.

6 天之前 · 【報道関係者各位】ノバルティス ファーマ株式会社の2025年4月11日付けプレスリリース『ノバルティスの放射性リガンド療法[177Lu]Lu-PSMA-617、PSMA陽性転移性去勢抵抗性前立腺がんに対する化学療法前の早期使用としてFDA承認取得 』です。

2025年2月18日 · To this end, the long-term follow-up (LTFU) safety study (NCT05803941) has been established. Findings from the LTFU study will be crucial for assessing delayed toxicities for patients with PSMA-positive metastatic prostate cancer treated with 177 Lu-PSMA-617 globally.