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

UK Government

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

Approval is based on results from a randomised, double-blind clinical trial involving 585 adults with extensive-stage small cell lung cancer who had not received prior treatment. Participants received either serplulimab or placebo, alongside chemotherapy.

Read UK Government press release

Michael Wonder

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Michael Wonder