Coherus Biosciences, Junshi Get FDA Complete Response Letter for Toripalimab

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 [e-mail]

(END) Dow Jones Newswires

May 02, 2022 07:50 ET (11:50 GMT)

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