MHRA approves UK’s first anti-PD-1 MAb for aggressive form of lung cancer

21 June 2025

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Hetronifly (serplulimab) 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.

The new marketing authorization was granted to Accord Healthcare, a subsidiary of Intas Pharmaceuticals.

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.

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