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UK patients granted early access to GSK’s endometrial cancer treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the use of anti-PD-1 therapy Jemperli® (dostarlimab) in combination with platinum-containing chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

Dostarlimab represents the first treatment breakthrough in this setting of endometrial cancer since 1990. It received Promising Innovative Medicine (PIM) designation in May 2022 and this subsequent positive opinion allows eligible patients to have access to dostarlimab prior to Marketing Authorisation (MA) and reimbursement in Great Britain.

Dostarlimab was accepted under the MHRA early access scheme based on study findings and the medical unmet need that exists in primary advanced or recurrent endometrial cancer. In 2022, dostarlimab became the first immunotherapy to be made available to treat advanced endometrial cancer on the NHS in England via the Cancer Drugs Fund (CDF) following treatment with chemotherapy. GSK recently received US Food and Drug Administration (FDA) file acceptance for primary advanced or recurrent endometrial cancer.

John Fleming, UK Oncology Medical Lead, GSK, said: “There is a significant unmet need in endometrial cancer and patients don’t have time to wait. The recent data from the RUBY clinical trial has shown a clear benefit for this group of patients and we are very pleased to have been able to work collaboratively with the MHRA to provide quick access to dostarlimab for eligible patients in Great Britain with primary advanced or recurrent endometrial cancer.”

Jack Harris, Vice-President UK Oncology, GSK, said: “Innovation in endometrial cancer has been lagging behind, but if approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer. Today’s news reinforces the importance of our work in the UK now and in the future. At GSK, we are committed to improving the lives of thousands of people impacted by cancer and we look forward to working with all stakeholders in the community towards approval and reimbursement for dostarlimab in this population.”

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Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.

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