The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with a specific type of advanced prostate cancer. It is used for prostate cancer that has spread to other parts of the body. This approval is for patients whose cancer is PSMA-positive and still responds to hormone therapy. Patients take Pluvicto along with another type of cancer drug called an androgen receptor pathway inhibitor (ARPI).Â
Prostate cancer cells often have a special protein on their surface called PSMA. Pluvicto works as a targeted radioactive treatment. It attaches directly to the PSMA protein on the cancer cells. Once attached, Pluvicto delivers radiation right into the cancer cells to damage their DNA and kill the cells. It also targets nearby cancer cells.Â
Before starting treatment, a healthcare provider will perform a special scan. This scan checks if the prostate cancer cells have the PSMA protein. Only patients with PSMA-positive cancer can receive Pluvicto.Â
The FDA approved Pluvicto based on results from a large study called PSMAddition. The study included 1,144 adult patients with PSMA-positive metastatic prostate cancer. Half of the patients received Pluvicto plus standard hormone therapy. The other half received standard hormone therapy alone.Â
Researchers looked at how long patients lived without their scans showing the cancer getting worse. Patients who took Pluvicto along with hormone therapy had a 28% lower risk of their cancer progressing or dying compared to those taking hormone therapy alone. At the time these study results were reported, overall survival results were not final yet.Â
Safety findings in the study were consistent with previous tests of the drug. Severe side effects occurred in about half of the patients taking Pluvicto. Some patients experienced low blood cell counts or severe kidney issues.Â
Pluvicto is given as an intravenous (IV) injection into a vein by trained healthcare providers. Patients receive the treatment once every six weeks for up to six total doses. Your healthcare provider will give you safety rules to protect others from radiation exposure. This includes drinking plenty of fluids and urinating often to help flush radiation out of your body. Patients must also limit close contact (less than 3 feet) with other people for two days or with children and pregnant women for 7 days. Avoid sexual activity for seven days after each dose.Â
The most common side effects of Pluvicto include fatigue, dry mouth, nausea, and low blood cell counts. Low blood cell counts can cause tiredness, pale skin, frequent infections, or easy bleeding. Patients may also experience kidney problems, such as urinating less often than normal. You should contact your healthcare provider right away if you notice any of these symptoms.Â
Pluvicto can cause temporary or permanent male infertility. It can also harm a fetus. Men with female partners who can become pregnant must use effective birth control during treatment and for 14 weeks after their last dose.Â
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