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Novartis' Pluvicto Approved in Europe for PSMA-Positive Castration-Resistant Prostate Cancer

NEW YORK – The European Commission on Tuesday approved Novartis' targeted radioligand therapy Pluvicto (lutetium vipivotide tetraxetan) with androgen deprivation therapy for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.

The Pluvicto-androgen deprivation therapy combination can also be used with or without androgen receptor pathway inhibition in these patients. Patients should receive androgen receptor pathway inhibition treatment and taxane-based chemotherapy before getting Pluvicto.

The EC approved the radioligand treatment after reviewing results from the Phase III VISION trial. Patients on Pluvicto plus standard-of-care treatment in the study had a 38 percent reduction in the risk of death and a 60 percent reduction in the risk of radiographic disease progression or death compared to patients on standard of care. About a third (30 percent) of patients treated with Pluvicto in the study responded to the therapy, versus 2 percent in the standard-of-care arm.

In May, the US Food and Drug Administration also approved Pluvicto as an option for previously treated, PSMA-positive metastatic castration-resistant prostate cancer. However, the US approval was for Pluvicto alone, not in combination with androgen deprivation therapy. The FDA also approved Novartis' gallium-68-labeled imaging product Locametz (gallium Ga 68 gozetotide) for identifying prostate cancer patients who have PSMA-positive lesions and are eligible for Pluvicto.

This month, Novartis said it hopes to gain another approval in an earlier line of treatment for Pluvicto, and plans to submit data to the FDA next year from the Phase III PSMAfore trial showing treatment benefit in metastatic PSMA-positive castration-resistant prostate cancer patients who haven't received prior chemotherapy.