Junshi and Coherus Resubmit BLA for Nasopharyngeal Cancer Treatment Candidate

The FDA has accepted Junshi Biosciences and Coherus BioSciences’ resubmission of its Biologics License Application (BLA) for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma.

The resubmission follows a Complete Response Letter that the FDA sent to the two companies in May, requesting a quality process change that the companies are addressing.

The resubmitted BLA also includes a request to approve toripalimab as monotherapy for the second-line or later treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.

The FDA said the resubmission review timeline would be six months because it will need to do onsite inspections in China. The agency has set a decision date of Dec. 23 on the BLA.