GSK’s Jemperli plus chemotherapy is now approved for patients with a tumour abnormality called mismatch repair deficient / microsatellite instability-high by slowing the progression of the disease
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has cleared the use of GSK’s Jemperli (dostarlimab) for use along with chemotherapy in the treatment of certain types of endometrial cancer in adults.
Jemperli is a monoclonal antibody therapy designed to block a receptor called PD-1 on certain cells of the immune system.
The new indication is for patients with a tumour abnormality called mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H). It is an advanced cancer stage when first diagnosed or has returned after previous therapy.
MHRA, the executive agency of the Department of Health and Social Care, granted the marketing authorisation to GSK for people in the UK including those in Northern Ireland.
The approval makes Jemperli the only treatment for people with certain types of advanced or recurrent endometrial cancer.
It can be used along with chemotherapy to slow down the progression of these cancers, thus improving life expectancy for patients.
During the treatment, the patients are administered through a drip over 30 minutes in hospitals under the supervision of a cancer specialist.
According to MHRA, the monoclonal antibody is the first medicine licensed as first-line treatment for primary advanced or recurrent endometrial cancer.
Jemperli has been approved by the US Food and Drug Administration (FDA) via Project Orbis, a global collaboration between the health regulators of several countries. This initiative evaluates and approves cancer medicines, facilitating faster patient access to care.
The MHRA will continue to closely monitor the safety and efficacy of Jemperli to check its side effects.
The UK’s health regulator regulates the working and safety of all medicines and medical devices in the UK.
Earlier this year, GSK obtained FDA approval for Jemperli plus chemotherapy to treat endometrial cancer patients.