Complete Response Letter for toripalimab + gemcitabine + cisplatin and as monotherapy for metastatic nasopharyngeal carcinoma..
Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. announced that the FDA, has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable. Coherus and Junshi Biosciences plan to meet with the FDA directly 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, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.
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