FDA Approves Novartis' Pluvicto As First Targeted Radioligand Therapy For Prostate Cancer

The FDA approved Novartis AG's NVS Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat patients with a type of advanced prostate cancer that has spread to other parts of the body.
Pluvicto is a targeted radioligand therapy for adult patients who have already undergone other anticancer treatments.
The company said it had submitted marketing authorization for Pluvicto to the European Medicines Agency and other health authorities.
According to Novartis, two late-stage studies evaluating Pluvicto in earlier lines of treatment for metastatic prostate cancer are underway.
The approval is based on the Phase 3 VISION trial, which demonstrated that participants treated with Pluvicto plus SOC had a 38% reduction in the risk of death and a statistically significant reduction in radiographic disease progression or death.
About 30% of patients with evaluable disease at baseline demonstrated an overall response with Pluvicto plus SOC, compared to 2% in the SOC alone arm.
Price Action: NVS shares are up 0.57% at $86.04 during the premarket session on the last check Thursday.