Jemperli - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

dostarlimab

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.

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¹New text in bold

CHMP post-authorisation summary of opinion for Jemperli (II-23)

AdoptedReference Number: EMA/CHMP/445059/2023

Key facts

• Name of medicine:
  Jemperli
• EMA product number:
  EMEA/H/C/005204
• Active substance:
  dostarlimab
• International non-proprietary name (INN) or common name:
  dostarlimab
• Therapeutic area (MeSH):
  Endometrial Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01FF07
• 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.

• Marketing authorisation holder:
  GlaxoSmithKline (Ireland) Limited
• Date of opinion:
  12/10/2023
• Status:
  Positive