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Randomized Controlled Trial
. 2023 May 1;29(9):1651-1657.
doi: 10.1158/1078-0432.CCR-22-2875.

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

Jaleh Fallah  1 , Sundeep Agrawal  1 , Haley Gittleman  1 , Mallorie H Fiero  1 , Sriram Subramaniam  1 , Christy John  1 , Wei Chen  1 , Tiffany K Ricks  1 , Gang Niu  1 , Anthony Fotenos  1 , Min Wang  1 , Kelly Chiang  1 , William F Pierce  1   2 , Daniel L Suzman  1 , Shenghui Tang  1 , Richard Pazdur  1   2 , Laleh Amiri-Kordestani  1 , Amna Ibrahim  1 , Paul G Kluetz  1   2
Affiliations
Randomized Controlled Trial

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

Jaleh Fallah et al. Clin Cancer Res. .

Abstract

On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-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 177Lu-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 177Lu-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 177Lu-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 177Lu-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 177Lu-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 177Lu-PSMA-617 for this indication.

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Conflict of interest statement

Disclosure of Potential Conflicts of Interest:

No potential conflicts of interest were disclosed.

Figures

Figure 1.
Figure 1.. Kaplan-Meier Plot of Overall Survival in VISION.
(Figure adapted from FDA’s Multi-Disciplinary Review; there are no restrictions on its use; ref .)
See this image and copyright information in PMC

References

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