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Non-small cell lung cancer is the most common form of lung cancer, accounting for around 80 to 85 out of 100 cases. It can be one of three types: squamous cell carcinoma, adenocarcinoma or large-cell carcinoma.

Sugemalimab is a monoclonal antibody (a type of protein designed to recognise and attach to a specific target in the body). It works by attaching to the target called programmed death-ligand 1 (PD-L1). Cancer cells with PD-L1 may switch off some cells of the immune system. By blocking PD-1, sugemalimab stops the cancer switching off immune cells and increases the immune systems ability to kill cancer cells.?

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

Enabling safe access to high quality, safe and effective medicines is a key priority for us.

Were assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met.

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

Sugemalimab is given to the patient in a hospital or clinic under the supervision of an experienced doctor. The patients doctor will give them sugemalimab through an infusion (drip) into a vein over 60 minutes every 3 weeks.

Clinical trials showed that sugemalimab in combination with platinum-based chemotherapy was more effective than placebo (a dummy treatment) in patients with Stage 4 metastatic lung cancer. The main measure of effectiveness was survival without worsening (progression) of the cancer. Patients who had sugemalimab treatment lived on average 9.0 months without the disease getting worse, compared with 4.9 months for patients who did not receive sugemalimab.

During clinical studies, common side effects included a decreased number of red blood cells that carry oxygen around your body, increased blood levels of liver enzymes, sugar, triglycerides, and cholesterol, decreased blood levels of calcium, potassium, sodium and thyroid hormone, increased levels of protein in the urine, and numbness, tingling or decreased sensation in part of the body.

As with any medicine, the MHRA will keep the safety and effectiveness of sugemalimab 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 30 October 2024 to CStone Pharmaceuticals

• This product was submitted and approved via a National 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 within 7 days of approval.?

• 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.?

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 02

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