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FDA Approvals, News & UpdatesProstate Cancer

Pluvicto FDA Approved for Men with PSMA-Positive Metastatic Prostate Cancer

April 2022 Vol 8 No 2

On March 23, 2022, the FDA approved a novel therapy, Pluvicto (lutetium Lu 177 vipivotide tetraxetan; from Novartis/Advanced Accelerator Applications), for the treatment of adult men with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer after receiving an androgen receptor inhibitor and taxane-based chemotherapy.

Pluvicto is the first FDA-approved targeted radioligand therapy for patients with metastatic prostate cancer that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle).

Oliver Sartor, MD

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

On the same day, the FDA approved Locametz (gallium Ga 68 gozetotide), a radioactive diagnostic agent used for PET scanning of PSMA-positive lesions and for selecting patients with metastatic prostate cancer who should receive Pluvicto. This is the first radioactive diagnostic agent approved by the FDA for selecting patients for a radioligand therapeutic agent.

The approval of Pluvicto was based on results of the VISION study, a randomized, multicenter, open-label clinical trial of 831 patients with progressive, PSMA-positive metastatic prostate cancer. The patients were divided into 2 groups: 551 patients received Pluvicto plus best standard of care, and 280 patients received best standard of care alone. The patients received Pluvicto every 6 weeks for up to 6 doses plus best standard of care or best standard of care alone.

The overall survival was significantly better with Pluvicto plus best standard of care compared with best standard of care alone. The average overall survival was 15.3 months with Pluvicto plus best standard of care compared with 11.3 months with best standard of care alone.

The most common side effects with Pluvicto were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened in patients who received Pluvicto were decreased levels of lymphocytes, hemoglobin, leukocytes, platelets, calcium, and sodium.

Treatment with Pluvicto may be associated with several risks, including risk of exposure to radiation, myelosuppression, and kidney side effects.

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Last modified: April 15, 2022

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