Resubmission of BLA application of toripalimab for the treatment of nasopharyngeal carcinoma.- Coherus Biosciences + Shanghai Junshi Biosciences.
Shanghai Junshi Biosciences Co., Ltd. announces to that the FDA has accepted for review the resubmission of the Biologics License Application for toripalimab, in combination with gemcitabine and cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
The FDA has set the Prescription Drug User Fee Act (“PDUFA”) action date on 23 December 2022.
Coherus BioSciences, Inc., plans to launch toripalimab in the United States in the first quarter of 2023, and toripalimab will be the first and only immuno-oncology agent for NPC in the United States.
The toripalimab BLA is supported by the results from JUPITER-02, a randomized, double blind, placebo-controlled, international multi-center Phase III clinical study, as well as POLARIS-02, a multi-center, open-label, pivotal Phase II clinical study.
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