- The FDA approved Novartis AG's (NYSE: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.
