On 12 October 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Jemperli. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.
The CHMP adopted a new indication for the treatment of endometrial cancer in combination with carboplatin and paclitaxel. For information, the full indications for Jemperli will be as follows1:
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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold
CHMP post-authorisation summary of opinion for Jemperli (II-23)
English (EN) (99.86 KB - PDF)