Shanghai Junshi Biosciences Co., Ltd has disclosed that the Singapore Health Sciences Authority (HSA) accepted the New Drug Application (NDA) for toripalimab. This application includes the use of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). Additionally, it covers the use of toripalimab as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression after platinum-containing chemotherapy. The HSA has granted priority review designation to the NDA.
The NDA was submitted through Project Orbis, an initiative led by the US Food and Drug Administration's Oncology Center of Excellence (OCE). Project Orbis facilitates concurrent submission and review of oncology drugs by regulatory partners globally. Toripalimab is the first Chinese oncology drug included in Project Orbis, aiming to expedite patient access to new cancer treatments internationally.
Toripalimab, an anti-PD-1 monoclonal antibody, has been approved for seven indications in China, with three supplementary new drug applications currently under regulatory review. The drug has also received approvals for two NPC indications in the US, with marketing approval applications under review in the European Union, UK, Australia, and Singapore.
The NDA is supported by data from JUPITER-02, a Phase 3 clinical study for first-line NPC treatment, and POLARIS-02, a Phase 2 study for recurrent or metastatic NPC. Results from JUPITER-02 demonstrated that toripalimab, in combination with chemotherapy, significantly improved progression-free survival and overall survival compared to chemotherapy alone, with a manageable safety profile. POLARIS-02 showed durable antitumor activity in patients with recurrent or metastatic NPC who had failed previous chemotherapy.
Toripalimab's broad clinical trials cover various tumor types, reflecting its potential in treating cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.
NPC is a malignant tumor affecting the nasopharyngeal mucosal epithelium, with limited treatment options due to its location. Toripalimab's potential in treating NPC aligns with its inclusion in Project Orbis, demonstrating its significance in the global oncology landscape.