FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer

被引：137

作者：

Fallah, Jaleh ^{[1
,3
]}

Agrawal, Sundeep ^{[1
]}

Gittleman, Haley ^{[1
]}

Fiero, Mallorie H. ^{[1
]}

Subramaniam, Sriram ^{[1
]}

John, Christy ^{[1
]}

Chen, Wei ^{[1
]}

Ricks, Tiffany K. ^{[1
]}

Niu, Gang ^{[1
]}

Fotenos, Anthony ^{[1
]}

Wang, Min ^{[1
]}

Chiang, Kelly ^{[1
]}

Pierce, William F. ^{[1
,2
]}

Suzman, Daniel L. ^{[1
]}

Tang, Shenghui ^{[1
]}

Pazdur, Richard ^{[1
,2
]}

Amiri-Kordestani, Laleh ^{[1
]}

Ibrahim, Amna ^{[1
]}

Kluetz, Paul G. ^{[1
,2
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

[3] US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA

来源：

CLINICAL CANCER RESEARCH | 2023年 / 29卷 / 09期

关键词：

D O I：

10.1158/1078-0432.CCR-22-2875

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as Lu-177-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended Lu-177-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks for up to six doses, or until disease progression or unacceptable toxicity. The FDA granted traditional approval based on VISION (NCT03511664), which was a randomized (2:1), multicenter, open-label trial that assessed the efficacy and safety of Lu-177-PSMA-617 plus best standard of care (BSoC; n = 551) or BSoC alone (n = 280) in men with progressive, PSMA-positive mCRPC. Patients were required to have received >= 1 androgen receptor pathway inhibitor, and one or two prior taxane-based chemotherapy regimens. There was a statistically significant and clinically meaningful improvement in overall survival (OS), with a median OS of 15.3 months in the Lu-177-PSMA-617 plus BSoC arm and 11.3 months in the BSoC arm, respectively (HR: 0.62; 95% confidence interval: 0.52-0.74; P < 0.001). The most common adverse reactions (>= 20%) occurring at a higher incidence in patients receiving Lu-177-PSMA-617 were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in >= 30% of patients receiving Lu-177-PSMA-617 were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. This article summarizes the FDA review of data supporting traditional approval of Lu-177-PSMA-617 for this indication.

引用

页码：1651 / 1657

页数：7

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