Novartis Pluvicto™ Approved by FDA as First Targeted Radioligand Therapy for Advanced Prostate Cancer

Novartis announced this week that the US Food and Drug Administration (FDA) granted approval for PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of patients with PSMA positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC).

“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, MD, Medical Director at Tulane Cancer Center via a press release. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”

Pluvicto stands as the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC. The treatment combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). The company reported that Pluvicto is expected to be available for use within weeks.

This FDA approval of Pluvicto is based on the results of the Phase III VISION trial, which showed that PSMA-positive mCRPC patients previously treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy who received Pluvicto plus standard of care (SOC) had improved overall survival compared to SOC alone. Specifically, trial subjects treated with Pluvicto plus SOC saw a 38% reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death (rPFS) compared to SOC alone, the company reported.

“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland13. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and President at ZERO – The End of Prostate Cancer. “The approval of Pluvicto offers new hope to the mCRPC community.”