FDA Approves First Chinese-developed PD-1 Inhibitor for Nasopharyngeal Carcinoma Treatment

On October 27, 2023, the United States Food and Drug Administration (FDA) gave approval to LOQTORZITM (toripalimab-tpzi), the first Chinese developed PD-1 inhibitor to be used for the treatment of nasopharyngeal carcinoma (NPC).

This PD-1 inhibitor, developed in collaboration between Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., is set to help patients suffering from metastatic or recurrent locally advanced NPC and those with recurrent, unresectable or metastatic NPC exhibiting disease progression on or after a platinum-containing regimen. The PD-1 inhibitor is set to be used in combination with cisplatin and gemcitabine treatment modalities, as well as a standalone treatment option.

The FDA’s approval of this PD-1 inhibitor marks a significant milestone in the field of oncology and a positive development for global health. PD-1 inhibitors, playing a pivotal role in the inhibition of the programmed death-ligand 1 (PD-L1) pathway, work to disengage the “brakes” on immune cells, enabling them to detect and combat cancer cells effectively. It opens up a variety of treatment possibilities for NPC patients who may not respond favorably to conventional treatment measures or in scenarios where such measures are not appropriate.

For further information on the FDA’s approval of the PD-1 inhibitor, you can read the article published by Knobbe Martens, which provides an in-depth look into the specifics of the approval process and the long-term implications for global health.