The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation for GlaxoSmithKline’s (GSK) Jemperli (dostarlimab) to treat adult patients with certain types of endometrial cancer.
The treatment is indicated for usage as a first-line therapy for patients with primary advanced or recurrent disease.
Individuals with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancers who are at an advanced stage or have experienced recurrence following prior therapy are eligible to receive the treatment.
Jemperli should be used along with chemotherapy to cut down disease progression, thereby enhancing life expectancy.
Hypothyroidism, rash or dryness on the skin, fever and higher levels of liver enzyme in the blood are frequent side effects.
Dostarlimab is a monoclonal antibody that hinders the programmed cell death protein 1 (PD-1) receptor on some cells of the immune system to fight cancer.
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Jemperli received approval under Project Orbis, an international collaboration that assesses and authorises potential cancer drugs.
The Australia Therapeutics Goods Administration, the Brazilian regulatory agency, Health Canada, Israel’s Ministry of Health, the MHRA, Singapore’s Health Sciences Authority, Swissmedic and the US Food and Drug Administration belong to the partnership.
In a press statement, the MHRA stated: “As with any medicine, the MHRA will keep the safety and effectiveness of Jemperli under close review.
“Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website or by searching the Google Play or Apple App stores for MHRA Yellow Card.”