Posted by Michael Wonder on 12 Aug 2021
Junshi Biosciences and Coherus announce U.S. FDA breakthrough therapy designation granted for toripalimab for first-line treatment of nasopharyngeal carcinoma
12 August 2021 - First-line nasopharyngeal indication and second/third line indications to be concurrently submitted 3Q 2021 in the toripalimab biologics licence application.
Shanghai Junshi Biosciences and Coherus BioSciences today announced that the United States FDA has recently granted breakthrough therapy designation for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
The FDA had earlier granted breakthough therapy designation for toripalimab monotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.
