Toripalimab (brand name: Loqtorzi) is a new investigational medicine for the treatment of advanced nasopharyngeal carcinoma (NPC). Toripalimab is an anti-PD-1 monoclonal antibody that boosts the body’s immune system response to cancer cells. This medicine is given as an intravenous infusion.

Is toripalimab available yet?

Toripalimab is not an FDA-approved medicine yet, and will not be available until it has been approved.

The application for the approval (Biologics License Application (BLA) for toripalimab has been made to the FDA, and an approval date is expected in the near future. The application for FDA approval was supported by the Phase II clinical study POLARIS-02 and the Phase 3 clinical trial JUPITER-02.

What is toripalimab used for?

The FDA Biologics License Application for toripalimab is

• as a first treatment for advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), when used together with gemcitabine and cisplatin
• as a second-line or later treatment for recurrent or metastatic nasopharyngeal carcinoma, after having platinum-containing chemotherapy Loqtorzi can be used as monotherapy.

Toripalimab is being studied to treat other types of cancers and in the future may be used for more cancers. The FDA has granted Fast Track designation for toripalimab to be used for the treatment of mucosal melanoma and it has Orphan Drug designations for the treatment of esophageal cancer, mucosal melanoma, nasopharyngeal carcinoma, and small cell lung cancer (SCLC), and soft tissue sarcoma.