Keytruda (pembrolizumab), Merck Sharp & Dohme B.V.

On 14 November 2024, 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 Keytruda. 

The CHMP adopted a new indication as follows:

Malignant pleural mesothelioma (MPM)

• Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.

The full indications for Keytruda is described in the Summary of Opinion.

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 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.

(1) New text in bold, removed text as strikethrough