Radiotherapy With Hormone Therapy Approved for Metastatic Prostate Cancer With Hormone Sensitivity
Lutetium Lu 177 vipivotide tetraxetan is the first radioligand therapy approved for metastatic prostate cancer that responds to hormone treatment.
The U.S. Food and Drug Administration (FDA) has approved lutetium Lu 177 vipivotide tetraxetan (Lu 177 vipivotide teraxetan; Pluvicto) in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously known as metastatic hormone-sensitive prostate cancer). Treatment eligibility is contingent on tumoral PSMA positivity as confirmed by a positron emission tomography (PET) test.
Lu 177 vipivotide tetraxetan is a radioligand therapy—a type of molecule composed of a radioactive isotope (Lu 177) conjugated to a small molecule that binds to a target (in this case, PSMA). The emissions from Lu 177 damage the DNA of the PSMA-expressing cells and those surrounding it. Androgen receptor pathway inhibitors are a class of therapy used to treat prostate cancer that shut down the androgen signaling that mAPMN/S prostate cancer cells use to proliferate.
Previously, Lu 177 vipivotide tetraxetan had been approved to treat metastatic castration-resistant prostate cancer. The new indication allows the therapeutic to also be used in patients with mAPMN/S prostate cancer.
The standard of care for mAPMN/S prostate cancer has long been androgen receptor pathway inhibitor therapy. The approval of Lu 177 vipivotide tetraxetan as a combination therapy with androgen receptor pathway inhibitor therapy gives patients with mAPMN/S prostate cancer a potentially more effective treatment option.
The approval was based on results from PSMAddition, a randomized, multicenter, open-label, phase III clinical trial that enrolled 1,144 patients with metastatic prostate cancer with at least one PSMA-positive metastatic lesion detected with a PET test. Patients had received no or minimal prior treatment. Trial participants were randomly assigned on a 1:1 basis to receive either Lu 177 vipivotide tetraxetan with an androgen receptor pathway inhibitor or an androgen receptor pathway inhibitor alone.
After a median follow-up of 23.6 months, patients who received both Lu 177 vipivotide tetraxetan and androgen receptor pathway inhibitor therapy were 18% less likely to have experienced radiographic disease progression than patients who received androgen receptor pathway inhibitor therapy alone.
The recommended dose of Lu 177 vipivotide tetraxetan with an androgen receptor pathway inhibitor therapy is 7.4 gigabecquerel (200 millicuries) administered intravenously once every six weeks until either a total of six doses have been administered or disease progression or unacceptable toxicity occurs.
Prostate cancer is, apart from nonmelanoma skin cancer, the most common cancer in men in the United States. About 9% of prostate cancers are diagnosed after the disease has already metastasized. According to federal statistics, it was estimated that 333,830 individuals would be diagnosed with prostate cancer and 36,320 patients would die of the disease in the United States in 2026.
The FDA rendered its decision on July 31, 2026. Check this resource for updated information on all therapeutics regulated by the FDA.