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The U.S. Food and Drug Administration has cleared Pluvicto for use with androgen receptor pathway inhibitors in adults whose prostate cancer is metastatic but still responds to hormone therapy, expanding treatment options for patients with PSMA‑positive disease.

Expanded eligibility for a targeted radiopharmaceutical

Under the new indication, patients must first undergo a PSMA PET scan using an FDA‑approved imaging agent such as Locametz to confirm sufficient expression of prostate‑specific membrane antigen on tumor cells. Once eligibility is established, clinicians can combine Pluvicto with one of several androgen receptor pathway inhibitors, including abiraterone, apalutamide, enzalutamide or darolutamide.

The dosing schedule calls for a 7.4 GBq (200 mCi) infusion every six weeks, up to six administrations, unless disease progression or intolerable side effects dictate an earlier stop.

Clinical trial data show delayed progression

Approval rests on the phase 3 PSMAddition trial, which enrolled 1,144 participants with PSMA‑positive metastatic prostate cancer. Patients were randomized to receive either Pluvicto plus standard hormone therapy or hormone therapy alone. The primary endpoint was radiographic progression‑free survival, the interval before imaging indicated tumor growth or spread.

Results indicated a 28 % reduction in the risk of disease progression or death for the combination arm. At the time of analysis, more than half of the subjects in both groups remained progression‑free, so median progression‑free survival had not yet been reached.

Researchers will continue to monitor overall survival outcomes. Safety observations aligned with earlier studies of the drug. The prescribing information warns of radiation exposure, myelosuppression, kidney toxicity, potential harm to a fetus and possible infertility. Patients are advised to discuss these risks with their oncology team before starting treatment.

The therapy expands options.

When compared with prior use patterns, this move mirrors earlier approvals of targeted therapies that shift from a salvage setting to earlier lines of care. By allowing Pluvicto to be administered while tumors are still hormone‑sensitive, clinicians may be able to keep disease under control longer, potentially postponing the need for additional systemic agents.

For patients, the practical impact is a new option that can be considered soon after diagnosis of metastatic disease, provided the PSMA PET scan confirms eligibility. Physicians will need to weigh the benefits of delayed progression against the known side‑effect profile and the logistics of repeated radiopharmaceutical infusions.

Regulatory documents note that the treatment may be halted before completing all six cycles if imaging shows tumor growth or if adverse events become severe. Ongoing follow‑up will clarify whether the combination also translates into longer overall survival.

Those interested in the therapy should consult their care team to determine if a PSMA PET scan is appropriate and to discuss the full risk‑benefit picture.

For more details on the FDA’s decision, see the agency’s release on the approval of lutetium Lu‑177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy.