1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022.
Shanghai Junshi Biosciences and Coherus BioSciences announced today that the United States FDA has accepted for review the biologics license application for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.