1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.
Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of nasopharyngeal carcinoma.