FDA grants priority review to first-line Toripalimab regimen in advanced nasopharyngeal carcinoma
Source: www.cancernetwork.com Author: Hayley Virgil A priority review was granted to toripalimab by the FDA for 2 indications in patients with advanced nasopharyngeal carcinoma. A biologics license application (BLA) for the combination of toripalimab (Tuoyi) plus gemcitabine and cisplatin for patients with advanced recurrent or metastatic nasopharyngeal carcinoma was accepted by the FDA and granted priority review, according to a press release from developer Junshi Biosciences.1 The BLA also covered the use of toripalimab monotherapy for the treatment of recurrent or metastatic disease following a platinum-containing regimen in the second line and beyond. The application for the anti–PD-1 monoclonal antibody is supported by findings from both the phase 2 POLARIS-02 trial (NCT02915432), which assessed toripalimab in previously treated and recurrent or metastatic nasopharyngeal carcinoma, and the phase 3 JUPITER-02 trial (NCT03581786), examining gemcitabine and cisplatin with or without toripalimab in recurrent of metastatic nasopharyngeal carcinoma.2,3 POLARIS-02 revealed durable clinical responses in those treated with toripalimab and JUPITER-02 identified notable improvements in progression-free survival (PFS). The Prescription Drug User Fee Act action date is currently set for April 2022. “We are excited by the continued progress of toripalimab toward a first marketing authorization outside of China,” Patricia Keegan, chief medical officer at Junshi Biosciences, said in a press release. “With the earlier approval in China, toripalimab became the world’s first immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma, bringing a novel therapy to a disease that has long lacked new drug development. We will cooperate closely with our partner, Coherus, [...]