FDA Expands New Treatment for Metastatic Prostate Cancer

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article repost from Memorial Sloan Kettering Cancer Center (click for source)
by: By Jim Stallard Tuesday, May 20, 2025

FDA Expands New Treatment for Metastatic Prostate Cancer: Targets a Protein Called PSMA
President Joseph Biden is one of an estimated 120,000 men living with stage 4 prostate cancer.  Fortunately, there are effective treatments that can slow or stop prostate cancer from progressing, even when it has metastasized, or spread to other parts of the body, typically the bones.

“Patients with metastatic prostate cancer typically receive hormonal therapy as a first treatment,” says Memorial Sloan Kettering Cancer Center medical oncologist and Prostate Cancer Section Head Michael Morris, MD. “Even when the disease develops resistance to hormonal therapy, there are exciting new treatments that are  effective.”

One new treatment uses radiopharmaceuticals to zero in on cancer cells to destroy them. The therapy, called 177Lu-PSMA-617 (Pluvicto®), includes a 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.

“At MSK, all patients with disease at risk for metastatic prostate cancer or who have relapsed disease on treatment are assessed by an imaging test, known as a PSMA-PET scan, that detects PSMA on the cells,” Dr. Morris says. “The patients who are resistant to hormonal therapy can receive 177Lu-PSMA-617 as part of their standard of care, and they are likely to feel better, function better, have less pain, and in some cases live longer than if they received an alternative.”

Recently, more patients became eligible for 177Lu-PSMA-617. In March 2025, the U.S. Food and Drug Administration expanded approval so it can be used earlier in treatment. Previously, the FDA had approved 177Lu-PSMA-617 only for patients with metastatic castration-resistant prostate cancer that had spread despite treatment with both an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy. 

But results from a phase 3 trial led the FDA to expand the use of 177Lu-PSMA-617 to patients who have not yet received taxane therapy. It showed that 177Lu-PSMA-617 prolonged progression-free survival (the period when the disease did not progress) in people who received it compared with those given a second hormonal therapy The trial, called PSMAfore, was reported in The Lancet.

“The expanded FDA approval substantially increases the number of patients now eligible for treatment with 177Lu-PSMA-617,” Dr. Morris says. “This type of precision medicine is a game changer for people whose prostate cancer has spread outside of the prostate despite treatment with hormonal therapy,”

Dr. Morris was the Principal Investigator of the study in the US, and the lead author of the Lancet publication.

“A standard approach for patients with metastatic prostate cancer has been to give drugs that target the androgen receptor, and then if that fails, to give chemotherapy,” Dr. Morris explains. “But some doctors and patients have been delaying taxane therapy due to side effects, and instead switch to a different hormonal therapy. This trial suggests we can proceed straight to 177Lu-PSMA-617.”

Prostate cancer is the second leading cause of cancer death in American males and kills more than 35,000 people in the U.S. every year. The new therapy, developed by the pharmaceutical company Novartis, has been a breakthrough for treating prostate cancer after it has spread and grown resistant to other drugs.

Theranostics: An Emerging Field

The FDA approval is the latest bold advance in the emerging field of theranostics, which uses radioactive substances to visualize cancer cells and destroy them without harming normal cells. It also enables doctors to determine how well a treatment is actually working.

“We have a theranostic motto, which is ‘We see what we treat, and we treat what we see,’ ” says nuclear medicine physician Lisa Bodei, Director of Targeted Radionuclide Therapy at MSK. She is an expert specializing in using radioactive materials to diagnose and treat cancer and played a key role in the treatment of MSK participants in the trial.

The original clinical trial, called VISION, showed that adding the drug to standard treatment slowed progression of prostate cancer. The treatment was recognized as a breakthrough when Dr. Morris presented the results in June 2021 at the annual meeting of the American Society of Clinical Oncology. Those results also were reported in The New England Journal of Medicine.