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Big Molecule Watch
October 31, 2023

FDA Approves LOQTORZI in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma

On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.  The active ingredient in LOQTOZI, toripalimab, is a monoclonal antibody that binds programmed death receptor-1 (PD-1) and blocks its interactions with ligands PD-L1 and PD-L2 with high potency, enabling the immune system to activate and kill the tumor.  According to the press release, LOQTORZI is the first and only FDA-approved agent for NPC patients.  LOQTORZI is expected to be available in the United States in Q1 2024.

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