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.
FDA has granted an accelerated approval to RP1 (vusolimogene oderparepvec) following the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
