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EMA Product

Jemperli

Product approved by European Medicines Agency (EU)

Basic Information

Jemperli

Regulatory Information

EMEA/H/C/005204

Authorised

April 21, 2021

February 25, 2021

11

August 1, 2024

Company Information

Ireland

12 Riverwalk Citywest Business Campus Dublin 24

GLAXOSMITHKLINE (IRELAND) LIMITED

Drug Classification

Additional Monitoring

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. JEMPERLI is indicated as monotherapy for the treatment of adult patients with dMMR/ MSI-H recurrent or advanced EC that has progressed on or following prior treatment with a platinum containing regimen.

Overview Summary

Jemperli is a cancer medicine for treating certain types of endometrial cancer (cancer of the womb) that are advanced or have come back. It is used: - together with carboplatin and paclitaxel (other cancer medicines, also called chemotherapy) in adults whose cancer is suitable for systemic therapy (treatment that affects the whole body); - on its own in adults whose cancer has got worse despite treatment involving a platinum-based cancer medicine. Jemperli is for endometrial cancer where the cancer cells have genetic abnormalities (called mismatch repair deficiency and high microsatellite instability) which prevent the cells from correcting mistakes that occur during cell division. Jemperli contains the active substance dostarlimab.

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