It concerns the treatment being combined with platinum-containing chemotherapy.
GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a positive opinion, under the Early Access to Medicines Scheme (EAMS), for the use of its anti-PD-1 therapy Jemperli.
It involves the treatment – also known as dostarlimab – being combined 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.
The positive scientific opinion is based on data emerging from the initial element of phase 3 randomised, double-blind RUBY trial researching dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel among patients with primary advanced or recurrent endometrial cancer.
Jack Harris, vice-president UK Oncology, GSK, explained: “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.”
He added: “This 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.”
John Fleming, UK oncology medical lead at GSK, elaborated: “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.”
Initially, dostarlimab received promising innovative medicine (PIM) designation in May 2022 and the subsequent positive opinion now allows eligible individuals to gain access to dostarlimab prior to marketing authorisation and reimbursement in Britain.
The aim of the EAMS is to deliver earlier availability of unlicensed medicines with considerable potential – and medicines used outside their licence – to patients in the UK that have a high unmet clinical need.
Endometrial cancer is found in the inner lining of the uterus and there are around 10,000 new cases of the disease reported every year in the UK.