By Colin Kellaher

 

Coherus BioSciences Inc. and Shanghai Junshi Biosciences Co. on Wednesday said the U.S. Food and Drug Administration has accepted for review their resubmitted application seeking approval of the cancer drug toripalimab.

Coherus, a Redwood City, Calif., biopharmaceutical company, and Shanghai-based pharmaceutical company Junshi said the FDA set a target action date of Dec. 23 for the application.

The agency earlier this year had turned away the application, seeking a quality process change that the companies said at the time would be readily addressable.

The application covers toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, or NPC, and as monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Coherus and Junshi said toripalimab, if approved, would be the first and only immuno-oncology agent in the U.S. for NPC, a cancer that occurs in the nasopharynx, which is located behind the nose and above the back of the throat.

Coherus said it plans to launch toripalimab in the U.S. in the first quarter of 2023 if approved.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

July 06, 2022 08:49 ET (12:49 GMT)

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