MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
Source: gov.uk (2025-06-20)

As with all products, we will keep its safety under close review

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.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:

“Patient safety is our top priority, which is why I am pleased to confirm approval of serplulimab to treat extensive-stage small cell lung cancer.

“As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.

“We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”

Serplulimab is given by intravenous infusion (into a vein) once every three weeks, in combination with chemotherapy (carboplatin and etoposide). Treatment can continue for as long as there is deemed clinical benefit.

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

Patients given serplulimab with chemotherapy lived on average for 15.4 months, compared with 10.9 months for those receiving chemotherapy and placebo.

A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.

As with any medicine, the MHRA will keep the safety and effectiveness of serplulimab under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors

The new marketing authorisation was granted on 20 June 2025 to Accord Healthcare Limited.

This product was submitted and approved via an international recognition procedure.

More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website (https://products.mhra.gov.uk/) within 7 days of approval.

For more information about small cell lung cancer, visit: https://www.nhs.uk/conditions/lung-cancer/

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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