Jemperli
Opinion
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
Key facts
| Name |
Jemperli |
| Agency product number |
EMEA/H/C/005204 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Endometrial Neoplasms
|
| Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
| Date opinion adopted |
12/10/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |