AstraZeneca's PD-L1 inhibitor Durvalumab gains nod for another indication in China

On November 24, the NMPA website showed that AstraZeneca's Durvalumab Injection secured approval for a new indication in China. Based on AstraZeneca's public disclosures and the drug's registration classification (Category 2.2), the newly approved indication is speculated to be for locally advanced non-small cell lung cancer (NSCLC).

Source: NMPA official website

Durvalumab is a humanized monoclonal antibody targeting PD-L1. It works by blocking the interaction between PD-L1 and its receptors PD-1 and CD80, thereby countering tumor immune evasion and reactivating suppressed immune responses.

To date, durvalumab has been approved in China for multiple indications, covering several cancer types including non-small cell lung cancer, small cell lung cancer, and biliary tract cancer.

In recent years, globally approved PD-L1 monoclonal antibodies for lung cancer include Roche's Atezolizumab—with indications covering urothelial carcinoma, NSCLC, and SCLC—and Avelumab, which was co-developed by Merck KGaA and Pfizer and is approved for Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma.