Posted by Michael Wonder on 02 May 2022
Junshi Biosciences and Coherus receive complete response letter from U.S. FDA for toripalimab BLA
2 May 2022 - The complete response letter requests a quality process change Junshi Biosciences and Coherus believe is readily addressable.
Shanghai Junshi Biosciences and Coherus BioSciences announced today that the U.S. FDA has issued a complete response letter for the biologics license application for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.
