Expanded Approval for Targeted Radiotherapy in Prostate Cancer
The FDA has approved the radiotherapy lutetium Lu 177 vipivotide tetraxetan for certain patients with metastatic prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) that expresses prostate-specific membrane antigen (PSMA) who have undergone treatment with an androgen receptor pathway inhibitor (ARPI) and for whom chemotherapy can be delayed.
Lutetium Lu 177 vipivotide tetraxetan is a radiotherapeutic that delivers a radioactive, cell-killing compound to PSMA-expressing cells, as well as to surrounding cells. While PSMA can be found on the surface of normal prostate cells, it is found at much higher levels on cancerous prostate cells.
The radiotherapeutic was previously approved to treat patients with PSMA-positive mCRPC that had been treated with both ARPI therapy and chemotherapy. This new approval expands the eligible patient population to include those who have not yet received and can delay taxane-based chemotherapy.
The expanded approval was based on results from the randomized, multicenter, open-label phase III PSMAfore clinical trial, in which 468 patients with PSMA-positive, ARPI-refractory mCRPC were randomly assigned (1:1) to receive either lutetium Lu 177 vipivotide tetraxetan or a different ARPI. Delaying chemotherapy was deemed appropriate for all enrolled patients.
Tumors treated with lutetium Lu 177 vipivotide tetraxetan were 59% less likely to progress compared with those treated with ARPI, with half of patients in each group experiencing at least 9.3 months and 5.6 months before progression, respectively. Overall survival did not significantly differ between the treatment arms, with median overall survival of 24.5 months and 23.1 months among patients in the lutetium Lu 177 vipivotide tetraxetan arm and ARPI arm, respectively.
The recommended dose is 7.4 GBq (200 mCi) intravenously every six weeks for 30 weeks, or until disease progression or unacceptable toxicity.
Prostate cancer is the most common non-skin cancer diagnosed in men, accounting for 15.4% of all new cancer cases regardless of gender. According to federal statistics, it was estimated that 313,780 individuals would be diagnosed with prostate cancer and 35,770 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on March 28, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.