Novartis’ Pluvicto Approved by FDA for Treatment of Advanced Prostate Cancer

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FDA has approved Novartis’ targeted radioligand therapy Pluvicto for the treatment of progressive PSMA-positive metastatic castration-resistant prostate cancer.

Novartis announced on March 23, 2022 that FDA has approved its targeted radioligand therapy Pluvicto for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC). These patients have already gone through androgen receptor pathway inhibition and taxane-based chemotherapy treatments.

Pluvicto combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle), providing another treatment option for patients with progressing mCRPC. The treatment is expected to be available to physicians and patients within weeks.

“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, M.D., medical director at Tulane Cancer Center. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”


“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. 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.”

Source: Novartis