Posted by Michael Wonder on 06 Jul 2022
Junshi Biosciences and Coherus announce FDA acceptance of resubmission of BLA for toripalimab for the treatment of nasopharyngeal carcinoma
6 July 2022 - The FDA has set a target action date of 23 December 2022 for the toripalimab BLA.
Shanghai Junshi Biosciences and Coherus BioSciences announced today that the United States FDA has accepted for review the biologics license application resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.
