On 19 September 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending changes to the terms of the marketing authorisation for the medicinal product pembrolizumab (Keytruda).
The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
The CHMP adopted extension to existing indication for the management of cervical cancer as follows:
Cervical cancer
KEYTRUDA, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.
The CHMP also adopted a new indication for the management of endometrial cancer:
Endometrial cancer
KEYTRUDA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.
Keytruda should be prescribed and supervised by a doctor experienced in the treatment of cancer.
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 these opinions.