FDA Expands Approval of Pluvicto® for Metastatic Prostate Cancer: Targets a Protein Called PSMA

This story was originally published in May 2025. It was last updated on August 6, 2026. 

An effective new treatment for metastatic prostate cancer is now available to a much larger group of people with the disease. The U.S. Food and Drug Administration (FDA) approved the therapy, Pluvicto^® (¹⁷⁷Lu-PSMA-617) to be given in combination with hormonal therapy as a frontline (first) treatment in patients with metastatic prostate cancer if a PET scan shows the cancer is positive for the PSMA protein.

The expanded FDA approval markedly increases the number of prostate cancer patients who can benefit from the new treatment.

Pluvicto is a radioactive molecule that selectively seeks out and attaches to a specific protein on the cancer cell surface called PSMA (prostate-specific membrane antigen). It delivers radiation that damages DNA and destroys the cancer cell. 

“This type of precision medicine has been a game changer for people whose prostate cancer has spread outside of the prostate,” says Memorial Sloan Kettering Cancer Center (MSK) medical oncologist and Prostate Cancer Section Head Michael Morris, MD. 

The latest approval is based on results from a phase 3 clinical trial called PSMAddition. Dr. Morris was a key leader of the study in the U.S. 

Results from the trial are reported in The Lancet.

Who is eligible for Pluvicto? 

To determine whether a patient is a candidate for Pluvicto, patients at MSK who have metastatic prostate cancer are assessed by an imaging test, known as a PSMA PET scan. 

Previously, Pluvicto was approved only for patients whose disease progressed despite receiving hormonal treatment. The new approval moves the treatment earlier: Patients with PSMA-positive prostate cancer can receive Pluvicto from the start, along with hormonal therapy.

“This new approval reflects a growing recognition that patients benefit from very early use of this radiopharmaceutical treatment in their disease,” Dr. Morris says. “Pluvicto has now been shown to be a superior way of treating metastatic prostate cancer — whether it is newly diagnosed, has progressed through hormone therapy, or has progressed through chemotherapy.”

Prostate cancer is the second leading cause of cancer death in American males and kills more than 36,000 people in the U.S. every year, according to the American Cancer Society. Pluvicto, developed by the pharmaceutical company Novartis, has been a breakthrough for treating prostate cancer after it has spread. 

How PSMA PET lights up cancer cells

PSMA is not found on most normal cells but is overexpressed in prostate cancer cells, especially those that have spread. Before receiving the therapy, patients are scanned with PSMA-directed PET imaging to make sure enough PSMA is present in the cells to make them likely to respond to the treatment. If so, they receive the radioactive drug by injection over four to six sessions, spaced six weeks apart.

The Molecular Imaging and Therapy Service, led by Heiko Schöder, played a key role in the development and testing of a slightly different PSMA-directed imaging technology at MSK.

“This advance is the result of years of work by the community of physicians promoting the use of PSMA agents,” Dr. Schöder says. “It’s gratifying to see a collaborative effort result in a breakthrough that has the potential to make a difference for so many patients with advanced prostate cancer.”

A new lifeline

Even before the latest approval, Pluvicto had already made a difference in the lives of patients who thought they had run out of options. For Frank Shieh, MD, the new treatment stopped his metastatic (stage 4) prostate cancer in its tracks. Despite surgery, radiation, and hormone-blocking drugs after his diagnosis in 2010, the prostate cancer kept returning, eventually spreading to his bones. His PSA level, a marker for prostate cancer, was rising, suggesting the cancer was still progressing.

A physician himself, Dr. Shieh knew his situation was growing desperate. By 2022, his only option was to start chemotherapy, a daunting prospect for someone 83 years old. He connected with MSK physician-scientist Yu Chen, MD, PhD, who proposed that Dr. Shieh join a clinical trial at MSK testing Pluvicto.

“At that point, I was willing to try anything,” Dr. Shieh says. “The cancer had stayed in my body for so many years, and I was anxious to get rid of it.”

Dr. Shieh received five injections of Pluvicto for five months. By the end of treatment, his PSA had dropped dramatically and has remained extremely low for three years.

“It’s been a relief to be able to go on with normal life without the cancer growing or having to deal with the effects of chemotherapy,” he says. “Being a doctor — and my wife is a nurse — we want to do what we can to make sure patients are aware these treatments are there to help them.”

It will be a lifeline for more people like Dr. Shieh, who is deeply grateful for the extra years he has been given with his wife and family. Dr. Shieh enjoys playing piano, which relaxes and soothes his mind. He also plays a lot of golf and recently took up pickleball. They enjoy visiting their four daughters — two of whom are doctors themselves — and seven grandchildren.

“I have been involved in the PSMA research since the end of my fellowship at MSK in the late 1990s,” says Dr. Morris, “It’s amazing to see it all come to fruition. The benefits these advances will bring to men with this common disease cannot be overstated.