Pluvicto receives positive CHMP opinion for prostate cancer

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The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radioligand therapy, in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen-positive, metastatic, castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane based chemotherapy.

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Traditional pathological features used to classify aggressive prostate cancer—such as high-grade disease, cancer extending outside the prostate and cancer involving the seminal vesicles—after surgery do not predict who will benefit more from adding hormone therapy to postoperative radiation, according to a study led by investigators at the UCLA Health Jonsson Comprehensive Cancer Center. 
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor for patients with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer.

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