Business
Coherus and Junshi Biosciences Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma
FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022 REDWOOD CITY, Calif. and SHANGHAI, China, Nov. 01, 2021 (GLOBE
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022 REDWOOD CITY, Calif. and SHANGHAI, China, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration (\"FDA\") has accepted for review the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment for 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. The FDA has granted Priority Review Designation for the toripalimab BLA and set a Prescription Drug User Fee Act (\"PDUFA\") action date for April 2022. The FDA is not currently planning to hold an advisory committee meeting to discuss the application. “Nasopharyngeal carcinoma is an aggressive tumor that currently has no FDA-approved immuno-oncology treatment options, and we believe that toripalimab in combination with chemotherapy, if approved, will establish a new standard of care for first line treatment of advanced NPC,” said Denny Lanfear, CEO of Coherus. “Toripalimab is the PD-1 cornerstone of our immuno-oncology strategy, and we are pleased that the FDA has accepted the BLA for review. Including the toripalimab application, Coherus now has three product candidate BLAs under review by the FDA, and our team is making rapid progress toward our goal to diversify and expand our commercial product portfolio.” “We are excited by the continued progress of toripalimab toward a first marketing authorization outside of China,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “With the earlier approval in China, toripalimab became the world’s first immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma, bringing a novel therapy to a disease that has long lacked new drug development. We will cooperate closely with our partner, Coherus, to leverage the FDA’s Priority Review designation to accelerate the completion of the BLA review and believe toripalimab, if approved, will bring an important new treatment option for NPC patients in the Unite...