The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new indication for dostarlimab (Jemperli, GlaxoSmithKline), a treatment for some types of endometrial cancer in adults.
Some cancers make PD-L1 and PD-L2 proteins that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. Monoclonal antibody dostarlimab has been designed to block the PD-1 receptor, preventing the cancer from switching off these immune cells, thereby increasing the immune system's ability to kill the cancer cells.
The MHRA highlighted that the drug could be used to treat patients that have a tumour abnormality called mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H)" when the cancer is at an advanced stage when first diagnosed, or has returned after previous treatment.
First Medicine Licensed For Primary Advanced or Recurrent Endometrial Cancer
There are almost 10,000 new cases of endometrial cancer each year in the UK according to Cancer Research UK, with almost 2500 deaths each year. "Around 1400 people are diagnosed with advanced cancer, and cancer recurs in around 1100 people," according to the Peaches Womb Cancer Trust.
The MHRA decided that Jemperli should be authorised for use together with chemotherapy "to slow the progression of these cancers, increasing life expectancy for patients". It said: "This is the first medicine licensed as first line treatment for primary advanced or recurrent endometrial cancer."
Jemperli has been authorised through Project Orbis, a global programme that reviews and approves promising cancer drugs, helping patients to access treatments more quickly.
The treatment is administered via a drip over 30 minutes in hospitals under the supervision of a doctor experienced in cancer treatment.
The most common side effects of the drug are underactive thyroid gland (hypothyroidism), skin rash, dry skin, fever, and increased liver enzyme levels.
"Robust and Fact-based" Judgement
Earlier this year the Peaches Womb Cancer Trust said it was "thrilled" that the National Institute for Health and Care Excellence had approved pembrolizumab (Keytruda, MSD), and lenvatinib (Lenvima, Eisai), and said that the treatments "will offer the potential for people with womb cancer to live longer, to feel well, and to live more independently, and with improved quality of life".
At the time, Professor Emma Crosbie, chair of trustees of Peaches Womb Cancer Trust, commented that the innovative new treatment regimen would benefit patients with advanced or recurrent endometrial cancer, "who currently have very few effective anti-cancer treatments available to them". She hoped that there would be "wider availability of more effective treatment options" for those affected by the cancer.
The MHRA emphasised its responsibility to regulate all medicines and medical devices to ensure "they work and are acceptably safe". It underlined that its work was underpinned by "robust and fact-based" judgements to ensure that the benefits justified any risks.
"As with any medicine, the MHRA will keep the safety and effectiveness of Jemperli under close review," reassured the Agency.