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Approval Alert Archive

In October 2023, the FDA approved frontline toripalimab-tpzi plus cisplatin and gemcitabine for adult patients with metastatic or locally advanced nasopharyngeal carcinoma, as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy.

177Lu-PSMA-617 for Pretreated PSMA+ Metastatic Castration-Resistant Prostate Cancer

In March 2022, the FDA granted approval to the targeted radioligand 177Lu-PSMA-617 for the treatment of patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously been treated with an androgen-receptor pathway inhibitor and taxane-based chemotherapy.