BRIEF—MHRA backs Jemperli, first anti-PD-1 monotherapy for recurrent or advanced endometrial cancer

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for UK pharma major GlaxoSmithKline’s Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody.

The approval is for Jemperli to be used in adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.

The same indication was approved by the European Commission and the US Food and Drug Administration April this year.

“The licensing of dostarlimab in the UK adds an important new option for a difficult to treat women’s cancer. Patients with dMMR/MSI-H advanced or recurrent endometrial cancer have been historically underserved, with limited treatment options and a poor prognosis. Today’s announcement will help to address the significant unmet need for effective tolerable treatment in this patient group," said Dr Rebecca Kristeleit, consultant medical oncologist, Guy’s and St Thomas’ NHS Foundation Trust.