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Breaking Ground in small cell lung cancer: First Anti-PD-1 Antibody Gains UK Approval

July 31, 2025

Patients fighting extensive stage small cell lung cancer (SCLC) now have new hope with UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently approving serplulimab (Hetronifly) a PD-1 inhibitor for treatment of small cell lung cancer (SCLC).

small cell lung cancer (SCLC) is a type of aggressive lung cancer that starts in lung airways and spreads easily to other parts of the body, it accounts for 10 to 15 % of lung cancer patients & often goes unnoticed until it reaches a late stage, making it a very difficult to treat type of cancer.

Serplulimab the first & only anti PD-1 monoclonal antibody approved for treatment of SCLC it is a targeted immunotherapy that enhances the immune response by inhibiting PD-1 a receptor utilized by certain cancer cells to evade immune detection. By blocking PD-1, Serplulimab enables immune cells to more effectively identify and eliminate cancer cells.

Approved based on data from a randomized, double-blind trial of 585 previously untreated adults with extensive-stage SCLC, serplulimab combined with chemotherapy (carboplatin and etoposide) extended median overall survival to 15.4 months, compared to 10.9 months with chemotherapy and placebo.

Administered via intravenous infusion every three weeks, treatment may continue as long as there is clinical benefit.

The MHRA confirms that the medicine meets standards for safety, quality, and efficacy, and will continue to monitor its safety post-approval. Side effects are listed in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC), available on the MHRA website. Suspected side effects should be reported via the Yellow Card scheme

 Learn more: MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer - GOV.UK

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