Posted by Michael Wonder on 01 Sep 2021
Coherus and Junshi Biosciences announce completion of rolling BLA submission to U.S. FDA for toripalimab for the treatment of nasopharyngeal carcinoma
1 September 2021 - Junshi Biosciences and Coherus Biosciences announced today the completion of the rolling submission of the biologics license application to the U.S. FDA for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.
The submission is supported by the results from POLARIS-02 and JUPITER-02.
