www.fdanews.com/articles/203085-gsk-earns-uk-approval-for-pd-1-inhibitor-jemperli-for-endometrial-cancer
GSK Earns UK Approval for PD-1 Inhibitor Jemperli for Endometrial Cancer
June 8, 2021
The UK’s Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorization to GlaxoSmithKline’s PD-1 inhibitor Jemperli for treating recurrent or advanced endometrial cancer.
The drug works by blocking PD-1 and PD-L1 proteins in the body’s immune system and cancer cells.
The authorization was supported by positive results from a trial in adults with mismatch repair deficient or microsatellite instability-high forms of the disease, following previous treatment with a platinum-based chemotherapy. Jemperli (dostarlimab) was found to have a disease-control rate of 57.1 percent.
Jemperli received FDA accelerated approval for the same indication in April.