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The U.S. Food and Drug Administration (FDA) recently approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with advanced prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body.

The FDA approval is welcome news and an important medical advancement for patients with progressing metastatic castration-resistant prostate cancer (mCRPC). Pluvicto™ can significantly improve survival rates for those who have limited treatment options for advanced prostate cancer

"Prostate cancer is the second-leading cause of death in men in the U.S. and those with metastatic prostate cancer have a 3 in 10 chance of surviving five years. This new therapy, lutetium Lu 177 vipivotide tetraxetan, is greatly needed for this group of patients,” said Dr. Ghassan El-Haddad, an associate member of the Diagnostic Imaging and Interventional Radiology Department and lead investigator overseeing the study at Moffitt Cancer Center. This was a multi-center multi-national trial and Moffitt was a top 10 center to recruit patients for the study.

The trial evaluated PluvictoTM (Lutetium Lu 177 vipivotide tetraxetan) for treatment of prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) in patients who were previously treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. PluvictoTM is a novel radioactive therapeutic that binds to prostate cancer cells that express PSMA. When bound, it emits therapeutic radiation to kill cancer cells without inflicting significant damage to surrounding normal tissue.

Of the 831 participants enrolled in the trial with evaluable disease at baseline, 30% had an overall response with PluvictoTM and Standard of care (SOC) compared to a 2% response with SOC alone. Participants also had a 38% reduction in risk of death and a 60% reduction in the risk of radiographic disease progression or death with PluvictoTM plus SOC compared to SOC alone. Notably, these therapy-driven improvements did not compromise the quality of life for patients.

The U.S. Food and Drug Administration (FDA) recently approved Pluvicto™ for the treatment of adults with PSMA-positive metastatic castration-resistant prostate cancer. This approval is welcome news for patients with limited treatment options as PluvictoTM can significantly improve their survival rates. One of the participants in the trial, Dr. Norman Busciglio, had this to say about his experience: “The therapy has been life-changing for me. After the first shot, my pain went away. My back and body no longer ached. It was amazing.” Busciglio is nearly two years post-therapy and says his cancer is stable and his prostate-specific antigen (PSA) level is non-detectable. Moffitt
Cancer Center is primed to be one of the only centers in Florida to offer PluvictoTM to patients in the near future.

Read a story about Dr. Norman Busciglio, a Tampa Bay area veterinarian, who participated in the study with a phenomenal outcome.

If you’d like to refer a patient to Moffitt Cancer Center, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.