FDA Issues CRL for Toripalimab

The FDA has issued a complete response letter for toripalimab, an anti-PD-1 monoclonal antibody to treat patients with metastatic nasopharyngeal carcinoma. Developed by Coherus BioSciences and Shanghai Biosciences, toripalimab is being studied in combination with gemcitabine and cisplatin for first-line treatment of this cancer.

The regulatory agency has requested a quality process change that the companies believe is readily addressable. Coherus and Junshi Biosciences plan to meet with the FDA and expect to resubmit the BLA by mid-summer 2022. The agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months because of required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.

“The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions,” Denny Lanfear, CEO of Coherus, said in a press release. “We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data.”

The BLA is supported by the results from clinical studies POLARIS-02 and JUPITER-02. The POLARIS-02 study is pivotal phase 2 clinical study, and the results were published online in January 2021 in the Journal of Clinical Oncology.

NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In the United States, there are currently no immunotherapies approved for the treatment of NPC.

The FDA has granted fast track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer.