Medicines Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (2 October 2023) authorised a new indication for Jemperli (dostarlimab), a treatment for some types of endometrial cancer in adults.
It can be used to treat patients that have a tumour abnormality called mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) when the cancer is at an advanced stage when first diagnosed or has returned after previous treatment.
Endometrial cancer is a cancer of the womb (uterus) lining and can occur in any person with a womb, although its most common in those who have been through the menopause.
Jemperli is now authorised to be used together with chemotherapy to slow the progression of these cancers, increasing life expectancy for patients. This is the first medicine licensed as first line treatment for primary advanced or recurrent endometrial cancer.
Jemperli has been authorised through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agncia Nacional de Vigilncia Sanitria in Brazil and Israels Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to access treatments more quickly.
The treatment is administered via a drip over 30 minutes in hospitals under the supervision of a doctor experienced in cancer treatment.
The active ingredient in this treatment, dostarlimab, is a monoclonal antibody. This is a type of protein designed to recognise and attach to a specific target substance in the body, helping a patients immune system fight cancer.
In this case, it has been designed to block a receptor (target) called PD-1 on certain cells of the immune system. Some cancers can make proteins that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. By blocking PD?1, dostarlimab stops the cancer switching off these immune cells, increasing the immune systems ability to kill the cancer cells.
The most common side effects of the medicine are underactive thyroid glands (hypothyroidism), skin rash, dry skin, high temperature or fever and increased liver enzyme levels in the blood.
As with any medicine, the MHRA will keep the safety and effectiveness of Jemperli 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 or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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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.?
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The MHRA is an executive agency of the Department of Health and Social Care.?
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The Marketing Authorisation was granted on 2 October 2023 to GlaxoSmithKline TS Ltd. There is existing provision to ensure that medical products can be made available to patients in the UK, including those in Northern Ireland. This includes todays announcement for Jemperli.
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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.
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The aim of Project Orbis is to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. For more information, see: Project Orbis - GOV.UK (www.gov.uk)
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For more information on endometrial cancer see: Womb (uterus) cancer - NHS (www.nhs.uk)
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For media enquiries, please contact the newscentre@mhra.