FDA approves Pluvicto with androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer
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- 4 août
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The expanded indication moves radioligand therapy into an earlier stage of metastatic prostate cancer, providing an additional treatment option for eligible patients before progression to castration-resistant disease.
The US Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer.
The approval expands Pluvicto's use into an earlier treatment setting, offering eligible patients a radioligand therapy alongside standard systemic treatment before progression to metastatic castration-resistant disease.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) |
Indication | In combination with an androgen receptor pathway inhibitor for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. Patients should be selected using Locametz® (gallium Ga 68 gozetotide) or another FDA-approved PSMA PET imaging agent. (U.S. Food and Drug Administration) |
Therapy Area(s) | Oncology; Prostate Cancer |
Geography | United States (FDA) |
What Happened | On 31 July 2026, the FDA approved Pluvicto in combination with an ARPI for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The decision expands Pluvicto's existing indication beyond metastatic castration-resistant prostate cancer into an earlier metastatic treatment setting and is based on results from the Phase III PSMAddition trial. (U.S. Food and Drug Administration) |
Why It Matters | The approval enables eligible patients to receive targeted radioligand therapy earlier in the course of metastatic disease while continuing standard androgen receptor pathway inhibition. It broadens treatment options for PSMA-positive disease, although appropriate patient selection remains dependent on PSMA PET imaging and long-term overall survival data are still maturing. (U.S. Food and Drug Administration) |
Supporting Context | In the PSMAddition trial, Pluvicto plus standard of care reduced the risk of radiographic progression or death compared with ARPI-based standard therapy alone. Overall survival data were immature at the time of approval, although an encouraging trend was reported. (U.S. Food and Drug Administration) |
Key Takeaway | FDA approval extends Pluvicto into the metastatic hormone-sensitive setting, introducing radioligand therapy earlier in the treatment pathway for eligible patients with PSMA-positive disease. (U.S. Food and Drug Administration) |
What to Watch | Longer-term overall survival results from PSMAddition and how rapidly PSMA PET-guided patient selection is incorporated into routine first-line metastatic prostate cancer care. (U.S. Food and Drug Administration) |
Primary Source | |
Relevant Date | 31 July 2026 |
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