The U.S. Food and Drug Administration has approved Pluvicto for men with a specific type of metastatic prostate cancer that has not yet become resistant to hormone therapy, marking a significant expansion of the treatment’s reach. The decision covers patients with PSMA-positive metastatic hormone-sensitive prostate cancer, or mHSPC, a group that previously had limited options beyond traditional hormone blockade and chemotherapy.
The approval is based on a late-stage trial showing that adding Pluvicto to standard androgen deprivation therapy reduced the risk of disease progression or death by 57 percent compared to hormone therapy alone. In the study, men receiving the radiopharmaceutical also had a 40 percent lower risk of death at the interim analysis, with median overall survival not yet reached in the treatment arm. The therapy works by delivering a targeted dose of radiation directly to prostate cancer cells that express the PSMA protein, sparing most healthy tissue.
Pluvicto is already approved for men with metastatic castration-resistant prostate cancer, a later stage where the disease has stopped responding to hormone suppression. This new indication moves the drug earlier in the treatment course, potentially changing the standard of care for men who are newly diagnosed with metastatic disease. Clinicians will use a PSMA-PET scan to confirm that a patient’s tumors are PSMA-positive before starting therapy, ensuring the drug is matched to the right biology.
Common side effects seen in the trial included fatigue, dry mouth, nausea, and low blood counts, which were generally manageable with supportive care. Because Pluvicto is a radioactive agent, patients receive it as an intravenous infusion in a specialized nuclear medicine setting, typically every six weeks for up to six cycles. The drug’s manufacturer is also studying it in earlier stages of prostate cancer and in combination with other systemic therapies, aiming to broaden its benefit further.
For patients and oncologists, this approval adds a powerful tool to the first-line arsenal for metastatic prostate cancer, a disease that affects tens of thousands of men each year. The next steps include real-world monitoring of long-term outcomes and broader access through treatment centers equipped for radiopharmaceutical delivery. With this expansion, Pluvicto now covers a continuum of metastatic disease, offering hope for more durable control from the moment of diagnosis.