FDA Approval Summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer.

Authors

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

Published in

Clinical cancer research : an official journal of the American Association for Cancer Research. Dec 05, 2022. Epub Dec 05, 2022.

Abstract

On March 23, 2022, the United States Food and Drug Administration (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 6 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 1 or 2 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 (Hazard ratio: 0.62, 95% CI: 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.

PMID:
36469000
Bibliographic data and abstract were imported from PubMed on 05 Dec 2022.

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