UK – MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 June 2025, approved serplulimab (Hetronifly) to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated, and has spread within the lungs or to other parts of the body.

SCLC is a fast-growing cancer that typically develops in the airways of the lungs. It accounts for 10-15% of lung cancer cases and is often diagnosed at a late stage when the cancer has already spread.

Serplulimab is a monoclonal antibody (a targeted therapy) that supports the immune system by blocking PD-1, a receptor some cancer cells use to avoid detection. By inhibiting PD-1, it helps immune cells recognise and destroy cancer cells more effectively…