GSK has announced that eligible endometrial cancer patients in the UK will be granted early access to its anti-PD-1 therapy Jemperli (dostarlimab) in combination with platinum-containing chemotherapy via the Early Access to Medicines Scheme (EAMS).

The EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

The combination has been specifically indicated to treat adults with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

Endometrial cancer is the most common gynaecological cancer in the UK, with approximately 10,000 new cases reported each year.

While it often has a better prognosis than other womb cancers if diagnosed early, patients with advanced or recurrent disease face limited treatment options and a poor prognosis.

The positive scientific opinion from the Medicines and Healthcare products Regulatory Agency (MHRA) was supported by positive data from part one of the phase 3 RUBY study evaluating Jemperli plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer.

In a group of patients with dMMR, MSI-H tumours, estimated progression-free survival at two years was 61.4% in the Jemperli cohort compared to 15.7% in those receiving placebo.

John Fleming, UK oncology medical lead at 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 [Jemperli] for eligible patients in Great Britain with primary advanced or recurrent endometrial cancer.”

The announcement comes just a month after the company’s respiratory syncytial virus (RSV) vaccine was approved by the European Commission for the prevention of RSV-caused lower respiratory tract disease in adults aged 60 years and older.

The decision, which followed a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation.

Source: pmlive.com