Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) by the Prescription Drug User Fee Action (PDUFA) date of December 23, 2022. The FDA previously communicated that an on-site inspection of Junshi Biosciences' manufacturing facility for toripalimab is required before the Agency can approve the application; however, they were unable to conduct the inspection during the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.

The FDA has granted priority review for the toripalimab BLA for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options. Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD?-?1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1's expression on the T-cell as a second method of restoring the body's immune response.

The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer ("SCLC").