MHRA Approves UK’s First Anti-PD-1 Monoclonal Antibody for Aggressive Lung Cancer
The MHRA has authorised the UK’s first anti-PD-1 monoclonal antibody, serplulimab, for adults with treatment-naïve extensive-stage small-cell lung cancer. The therapy is expected to improve survival and increase treatment options for one of the most aggressive lung cancers.
Introduction
Serplulimab, marketed as Hetronifly, has received regulatory approval from the MHRA for use in adults with extensive-stage small-cell lung cancer (ES-SCLC) who have not previously received treatment. This marks the first time a PD-1 immune checkpoint inhibitor has been authorised in the UK for this fast-progressing and hard-to-treat cancer type.
Clinical Benefits
In clinical trials, serplulimab significantly improved overall survival in combination with carboplatin and etoposide chemotherapy. Patients receiving the combination lived a median of 15.4 months compared to 10.9 months for those receiving chemotherapy alone. The therapy works by enabling the immune system to detect and attack tumour cells, offering a valuable new line of defence for patients with limited treatment options.
Mechanism of Action
Serplulimab is an anti-PD-1 monoclonal antibody. It blocks the PD-1 protein on T cells, preventing tumour cells from evading immune detection. By restoring immune system activity against cancer cells, serplulimab enhances the body’s natural ability to fight tumours. This is particularly important in SCLC, which is known for its rapid progression and poor prognosis.
MHRA Authorisation
The approval follows an expedited review supported by the MHRA’s International Recognition Framework. This allows the UK regulator to align with trusted global partners, ensuring faster access to safe and effective treatments for UK patients. Healthcare professionals are encouraged to report any adverse effects via the Yellow Card scheme.
Next Steps
Healthcare providers should familiarise themselves with the eligibility criteria and prepare for local adoption. Serplulimab is now authorised for NHS prescribing, and implementation guidance is expected to follow. Oncology teams should monitor patient outcomes and report safety data as part of pharmacovigilance requirements.
Citation:
Medicines and Healthcare products Regulatory Agency. (2025, 24 June). MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer. GOV.UK
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