Coherus Biosciences, Junshi Get FDA Complete Response Letter for Toripalimab
May 02 2022 - 08:05AM
Dow Jones News
By Michael Dabaie
Shanghai Junshi Biosciences Co. Ltd. and Coherus BioSciences
Inc. said they received a U.S. Food and Drug Administration
complete response letter, which indicates the agency won't approve
an application in its current form.
The letter is for the biologics license application for
toripalimab in combination with gemcitabine and cisplatin in the
first-line treatment of nasopharyngeal carcinoma. The BLA is also
for toripalimab monotherapy in the second-line or later treatment
of recurrent or metastatic NPC.
Coherus shares were down 3% to $8.76 premarket.
The letter requested a quality process change that Coherus and
Junshi Biosciences said they believe is readily addressable. Upon
receiving a complete response letter, the company has the option to
refile its application if it meets the criteria set out in the
letter.
Coherus and Junshi said they plan to meet with the FDA directly
and expect to resubmit the application by mid-summer 2022. The
FDA's review timeline for the BLA resubmission would be six months,
the companies said. The FDA said required onsite inspections have
been hindered by travel restrictions from the Covid-19 pandemic in
China, the companies said.
NPC is a type of aggressive cancer that starts in the upper part
of the throat behind the nose and near the base of skull. Due to
the tumor location, surgery is rarely an option and patients with
localized disease are treated mainly with radiation and
chemotherapy.
In 2021, Coherus in-licensed rights to develop and commercialize
toripalimab in the U.S. and Canada. Coherus and Junshi Biosciences
said they plan to file additional toripalimab BLAs with the FDA
over the next several years for other cancer types.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
May 02, 2022 07:50 ET (11:50 GMT)
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