(NMPA) of China granted an approval to its independently developed anti-PD-1 mAb AiRuiKa® (camrelizumab for injection) combined with gemcitabine and cisplatin (GP) as a first-line treatment for the patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). Camrelizumab becomes the first approved anti-PD-1 antibody for this indication globally. Except for this new indication, camrelizumab was approved in China for the indications of 1L NSCLC, 2L HCC, 2L EC, 3L r/r and cHL, ≥ 2L NPC. Up to this point, camrelizumab is the anti-PD-1 monoclonal antibody with the most approved indications in China. This New Drug Application (NDA) was granted priority review by NMPA.

The approval was based on a multicenter, randomized, double-blinded, phase 3 study (NCT03707509) that enrolled 263 recurrent or metastatic NPC patients. The interim result shows camrelizumab plus GP improved PFS compared with placebo plus GP, with a 49% lower risk of disease progression or death. The result was presented in an Oral Presentation at ASCO 2021 Annual Meeting. The study was accepted by The Lancet Oncology and will be published recently.

Camrelizumab combined with GP as the first-line treatment for the patients with recurrent or metastatic NPC has the potential to become the standard of care bringing benefits to more NPC patients.