News|Articles|July 31, 2026

FDA Approves Pluvicto Plus Hormone Therapy for Certain Patients With Metastatic Prostate Cancer

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Key Takeaways

FDA authorization moves ^177Lu-PSMA radioligand therapy into the metastatic hormone-sensitive setting for PSMA-positive disease, paired with an ARPI such as abiraterone, apalutamide, enzalutamide, or darolutamide.
Patient selection is contingent on PSMA PET using an FDA-approved agent (e.g., Locametz) to verify sufficient PSMA expression for target engagement and anticipated therapeutic benefit.
PSMAddition demonstrated a 28% reduction in risk of radiographic progression or death with Pluvicto plus ARPI versus ARPI alone; overall survival remains under follow-up and rPFS medians were unreached.
Administration is 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses, with discontinuation for progression or unacceptable toxicity, and labeled risks include radiation exposure, myelosuppression, and nephrotoxicity.

The FDA approved Pluvicto with hormone therapy for PSMA-positive metastatic prostate cancer, helping delay disease progression in patients.

The Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, a disease previously known as metastatic hormone-sensitive prostate cancer.

The July 31 approval expands the use of Pluvicto to patients whose prostate cancer has spread but has not yet become resistant to hormone therapy. The treatment is intended for patients whose tumors express prostate-specific membrane antigen (PSMA), a protein found on many prostate cancer cells.

Who Is Eligible for Pluvicto?

Before starting Pluvicto, patients must undergo a specialized PSMA PET scan using Locametz or another FDA-approved imaging agent. This scan helps determine whether the cancer cells produce enough PSMA for the treatment to be effective.

Pluvicto is used alongside an androgen receptor pathway inhibitor, a type of hormone therapy that blocks the signals prostate cancer cells need to grow. These therapies may include Zytiga (abiraterone), Erleada (apalutamide), Xtandi (enzalutamide) or Nubeqa (darolutamide).

Study Shows Pluvicto Delayed Disease Progression

The approval was based on results from the phase 3 PSMAddition clinical trial, which enrolled 1,144 patients with PSMA-positive metastatic prostate cancer.

Participants were randomly assigned to receive either:

Pluvicto plus an androgen receptor pathway inhibitor, or
An androgen receptor pathway inhibitor alone.

Researchers primarily measured radiographic progression-free survival, which is the length of time before scans show the cancer has grown or spread.

Patients who received Pluvicto in combination with hormone therapy experienced a 28% lower risk of disease progression or death compared with those who received hormone therapy alone.

At the time of the analysis, more than half of the patients in both treatment groups had not yet experienced disease progression, meaning the median radiographic progression-free survival had not yet been reached in either group. Researchers will continue following patients to determine whether the combination also improves overall survival.

What This Means for Patients

For people with PSMA-positive metastatic prostate cancer, this approval makes Pluvicto available earlier in treatment than before. Previously, the targeted radiopharmaceutical was generally used after the disease had progressed despite hormone therapy and other treatments. With this expanded approval, eligible patients may now receive Pluvicto alongside standard hormone therapy while their cancer is still responsive to androgen pathway treatment.

Although researchers are continuing to evaluate whether the combination helps patients live longer, the current findings show it can significantly delay the time before the cancer worsens. Delaying disease progression may help patients remain on their current treatment longer before needing additional therapies.

Patients interested in Pluvicto should speak with their care team about whether a PSMA PET scan is appropriate and whether their cancer meets the requirements for treatment.

Side Effects Were Consistent With Previous Studies

The safety profile of Pluvicto was similar to what has been seen in earlier studies.

The prescribing information includes warnings about:

Radiation exposure
Low blood cell counts (myelosuppression)
Kidney toxicity
Harm to an unborn baby if used during pregnancy
Potential infertility

Patients should discuss these risks with their oncology team before beginning treatment.

How Pluvicto Is Given

The recommended dose of Pluvicto is 7.4 GBq (200 mCi) administered once every six weeks for up to six doses. Treatment may be stopped earlier if the cancer progresses or if side effects become too severe.

The FDA's approval gives eligible patients with PSMA-positive metastatic prostate cancer another treatment option earlier in their care, adding a targeted therapy that may help keep the disease under control for longer when combined with standard hormone therapy.

Reference

FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. U.S. Food and Drug Administration. July 31, 2026. Accessed July 31, 2026.