Coherus and Junshi Biosciences Receive CRL from FDA for Toripalimab in combination with Gemcitabine and Cisplatin In metastatic nasopharyngeal carcinoma (NPC)

Shanghai Junshi Biosciences and Coherus BioSciences, Inc. (NASDAQ:CHRS) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC).

The complete response letter requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable.