Jemperli

Treatment with Jemperli must be started and supervised by a doctor experienced in treating cancer. The medicine can only be obtained with a prescription.

Jemperli is given by infusion (drip) into a vein over 30 minutes. The dose is 500 mg once every 3 weeks for the first 4 doses and then 1,000 mg every 6 weeks. Treatment can be continued as long as Jemperli continues to work. The doctor may interrupt Jemperli treatment or stop it altogether if certain side effects occur.

For more information about using Jemperli, see the package leaflet or contact your doctor or pharmacist.

The active substance in Jemperli, dostarlimab, is a monoclonal antibody, a protein that has been designed to block a receptor (target) called PD-1 on certain cells of the immune system (the body’s natural defences). Some cancers can make proteins (PD-L1 and PD-L2) that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. By blocking PD‑1, dostarlimab stops the cancer switching off these immune cells, thereby increasing the immune system’s ability to kill the cancer cells.

Jemperli was found effective in a study involving 108 women with endometrial cancer that was advanced or had come back and had got worse despite treatment that included a platinum-containing medicine. The cancers involved mismatch repair deficiency or high microsatellite instability. At follow up after at least 24 weeks, the cancer had shrunk or could no longer be detected in 43.5% of women receiving Jemperli.

The most common side effects with Jemperli (which may affect more than 1 in 10 people) are anaemia (low count of red blood cells), nausea (feeling sick), diarrhoea, vomiting, joint pain, itching, rash, fever and hypothyroidism (low levels of thyroid hormones). The most serious side effects are related to the medicine’s effects on the immune system, such as inflammation in various body organs and tissues, rash and reactions to the infusion.

For the full list of side effects and restrictions of Jemperli, see the package leaflet.

Endometrial cancer that has returned after treatment is difficult to treat with cancer medicines. The European Medicines Agency considered that the beneficial effects of Jemperli on endometrial cancer seem to last longer than with other treatments available in the EU. If this is confirmed, women treated with Jemperli are likely to live longer than those receiving other treatments. The side effects seen with Jemperli are in line with the way the medicine works and are acceptable.

The Agency therefore decided that Jemperli’s benefits are greater than its risks and it can be authorised for use in the EU.

Jemperli has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Jemperli has been given conditional authorisation, the company that markets Jemperli will provide data from an ongoing study on the medicine’s effectiveness, with patients followed up for at least 12 months. The company will also provide data from a study in patients with endometrial cancer when it is advanced or has come back and has not been treated with other cancer medicines; the study will look at Jemperli given together with other cancer medicines compared with these other cancer medicines given alone. 

The company that markets Jemperli will provide a patient card about signs and symptoms of immune system side effects of the medicine, and the need to get immediate medical help if these side effects occur.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jemperli have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Jemperli are continuously monitored. Side effects reported with Jemperli are carefully evaluated and any necessary action taken to protect patients.

Jemperli received a conditional marketing authorisation valid throughout the EU on 21 April 2021.