A Targeted Radiotherapy for Prostate Cancer 

The FDA has approved a radioactive compound and companion diagnostic test for patients with advanced prostate cancer. 

The U.S. Food and Drug Administration (FDA) has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for adult patients with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express a protein called prostate-specific membrane antigen (PSMA). The treatment is intended for patients who were previously treated with an androgen receptor inhibitor and chemotherapy. 

The FDA also approved gallium Ga 68 gozetotide (Locametz), a radioactive imaging agent designed to identify PSMA-positive tumors and select patients eligible for treatment with lutetium Lu 177 vipivotide tetraxetan. 

Lutetium Lu 177 vipivotide tetraxetan is a radiotherapy that combines a radioactive compound with a tag that targets it to prostate cancer cells expressing PSMA.  

The approval is based on results from a multicenter, open-label clinical trial that randomly assigned 831 patients with progressive PSMA-positive mCRPC to receive either lutetium Lu 177 vipivotide tetraxetan plus the standard of care or the standard of care alone. Patients receiving lutetium Lu 177 vipivotide tetraxetan had a median overall survival of 15.3 months as compared with 11.3 months among patients receiving the standard of care. 

Prostate cancer is the most common non-skin cancer diagnosed in men. According to federal statistics, an estimated 268,490 men will be diagnosed with prostate cancer in the U.S. in 2022. 

The FDA decision was rendered on March 23, 2022.