FDA Expands Approval of Lutetium Lu 177 Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer
On March 28th, 2025, the US Food and Drug Administration (FDA) expanded the approval of lutetium Lu 177 vipivotide tetraxetan for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibitors (ARPIs) and eligible to delay taxane-based chemotherapy. This expanded approval was based on results from the PSMAfore trial.
In this open-label, multicenter trial, 468 patients were randomized 1:1 to receive either 7.4 GBq of lutetium Lu 177 vipivotide tetraxetan every 6 weeks for up to 6 doses or a change in ARPI therapy. Patients in the ARPI arm who experienced disease progression were able to crossover into the experimental arm (n = 141). The primary end point was radiographic progression-free survival (rPFS). Key secondary end points included overall survival (OS) and safety.
At analysis, the median rPFS was 9.3 months in the lutetium Lu 177 vipivotide tetraxetan arm and 5.6 months in the ARPI arm (hazard ratio [HR] 0.41; 95% confidence interval [CI], 0.29 to 0.56; P <.0001). Median OS was 24.5 months and 23.1 months, respectively. The safety profile was consistent with prior studies.
Adverse events were consistent with those previously reported for lutetium Lu 177 vipivotide tetraxetan. Lutetium Lu 177 vipivotide tetraxetan may be associated with radiation exposure, myelosuppression, and renal toxicity.
The recommended dose of lutetium Lu 177 vipivotide tetraxetan is 7.4 GBq administered intravenously every 6 weeks for 6 doses or until disease progression or unacceptable toxicity.
Source:
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. Accessed on March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
