On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer indications. This means Keytruda® is now approved for 30 indications in Europe, including 5 for gynaecological cancer.
The first new indication is for Keytruda®, in combination with carboplatin and paclitaxel, for first line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. This indication was approved by the FDA in June 2024.
The second is Keytruda®, in combination with chemoradiotherapy, for treatment of FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. This indication was approved by the FDA in January 2024 and in Korea in April 2024.
The new indications received positive CHMP approvals in September 2024.