FDA Approves Pluvicto for Hormone-Sensitive Prostate Cancer - Takeaways - MDSpire
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FDA Approves Pluvicto for Hormone-Sensitive Prostate Cancer

The approval is based on phase 3 PSMAddition results showing reduced risk of disease progression or death with Pluvicto plus standard of care compared with standard of care alone, according to Novartis.

  • By

  • Kathryn Wighton

  • August 3, 2026

  • 3 min

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  • 1

    The FDA approved Pluvicto for adults with PSMA-positive metastatic hormone-sensitive prostate cancer.

  • 2

    The approval is based on the phase 3 PSMAddition trial, showing Pluvicto reduced disease progression risk by 28%.

  • 3

    An updated analysis indicated a 33% reduction in disease progression or death risk with Pluvicto plus standard care.

  • 4

    Grade 3 or higher adverse events occurred in 51% of patients receiving Pluvicto, compared to 43% with standard care.

  • 5

    Pluvicto is an intravenous radioligand therapy that targets prostate cancer cells expressing PSMA using lutetium-177.

Original Source(s)

FDA Approves Pluvicto for Hormone-Sensitive Prostate Cancer

  • by Kathryn Wighton

  • August 3, 2026

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