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# ‘Breakthrough’ Granted to Nasopharyngeal Carcinoma Drug
- URL: https://www.fdaweb.com/breakthrough-granted-to-nasopharyngeal-carcinoma-drug/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149925

FDA has granted a breakthrough therapy designation to Shanghai Junshi Biosciences and Coherus BioSciences for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Previously, the agency granted a similar designation for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Junshi Biosciences says it expects to complete a BLA for toripalimab plus chemotherapy for first-line NPC and for toripalimab monotherapy for second- or third-line NPC this quarter.  

The latest designation is supported by data from the Phase 3 JUPITER-02 clinical trial, which showed that toripalimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression free survival compared to chemotherapy alone, according to the companies.  

Toripalimab is described as an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). “Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells,” the companies say.