On 12 December 2024, the European Medicines Agency’s (EMA’s) 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 dostarlimab (Jemperli).
The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.
The CHMP adopted an extension to an existing indication as follows:
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
Previously, it was indicated in the first-line treatment in combination with carboplatin and paclitaxel for adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
For information, the full indication will be as follows:
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer 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 endometrial cancer 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, which will be published in the revised European public assessment report and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.