Coherus, Junshi Biosciences Say FDA Accepts Resubmission Of Toripalimab BLA

Coherus BioSciences, Inc. (CHRS) and Shanghai Junshi Biosciences Co., Ltd. announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for December 23, 2022. The Agency earlier communicated that the review timeline for the BLA resubmission would be six months, as onsite inspections in China would be required.

The travel restrictions related to the COVID-19 pandemic previously hindered the FDA's ability to complete required inspections. Coherus plans to launch toripalimab in the U.S. in the first quarter of 2023, if approved.

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