Coherus and Junshi Biosciences Announce FDA Acceptance of Toripalimab BLA

Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.  As we previously reported, earlier this year Coherus paid Junshi Biosciences $145 million for, inter alia, the U.S. and Canada rights to toripalimab.  According to the release, the FDA granted the application Priority Review Designation and set the target action date for April 2022.  Also according to the release, the FDA previously granted priority review for the toripalimab BLA for treatment of recurrent or metastatic NPC, Fast Track designation for its use in the treatment of mucosal melanoma, and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma.