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Serplulimab gets MHRA approval for treating small cell lung cancer

This cancer develops in the airways of the lungs and spreads fast within the lungs and other parts of the body

Lung Cancer

Serplulimab helps immune cells recognise and destroy cancer cells more effectively.

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The monoclonal antibody Serplulimab has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat adults with extensive-stage small cell lung cancer.

This cancer develops in the airways of the lungs and spreads fast within the lungs and other parts of the body.


It is often diagnosed at a late stage and accounts for 10-15 per cent of lung cancer cases.

Sold under the brand name Hetronifly, Serplulimab (a targeted therapy) 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.

MHRA interim executive director Julian Beach said, “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."

He said the medicine has met all the appropriate regulatory standards of safety, quality, and efficacy, and MHRA will continue to review its safety.

Patients who suspect they are having a side effect from this medicine can talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme.

Serplulimab is administered intravenously, in combination with chemotherapy.

The approval is based on results from a clinical trial involving 585 adults with extensive-stage small cell lung cancer, who had not received prior treatment.

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

The European Commission had approved serplulimab in February.

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