The U.S. Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). This expands the indication beyond the previously approved metastatic castration-resistant prostate cancer (mCRPC) setting.
The approval is based on the Phase III PSMAddition trial, which showed a significant improvement in radiographic progression-free survival (rPFS) and overall survival (OS) for patients receiving Pluvicto in combination with androgen deprivation therapy (ADT) compared to ADT alone. The trial met its primary endpoint, and the FDA granted priority review.
Pluvicto is a radioligand therapy that delivers a radioactive isotope directly to PSMA-expressing cancer cells. It is administered intravenously, typically every six weeks for up to six cycles. Common side effects include fatigue, dry mouth, and low blood cell counts.
This approval marks a significant step in the treatment of prostate cancer, offering a new option for patients with earlier-stage metastatic disease. The drug is developed by Novartis, which continues to evaluate its use in other prostate cancer settings.
