Coherus, Junshi: FDA Accepts Resubmission of Toripalimab Application
July 06 2022 - 9:04AM
Dow Jones News
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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