FDA Expands Approval for Pluvicto, Doubling Eligible Prostate Cancer Patients
The FDA has expanded the approval of Pluvicto, a radioligand therapy, for use in men with metastatic prostate cancer that still responds to hormone therapy. This decision nearly doubles the number of patients eligible for the treatment. Pluvicto, which is administered at licensed facilities, is combined with an androgen receptor pathway inhibitor. The approval is based on a Phase III trial showing a 28% reduction in disease progression risk. However, the therapy's availability is limited to centers with the necessary radioactive materials license.