Shanghai Junshi Biosciences Co., Ltd and Coherus BioSciences Inc. (CHRS) said Sunday that they have not received an action letter from the U.S. Food and Drug Administration 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.
According to the companies, 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, the FDA was 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.
Junshi Biosciences and Coherus said that they are actively engaged in ongoing discussions with the FDA to support the inspections and gain approval of toripalimab for patients with NPC in the U.S. as quickly as possible.
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.
For comments and feedback contact: editorial@rttnews.com
Business News