FDA approves Keytruda (pembrolizumab) for endometrial carcinoma and FIGO 2014 Stage III-IVA cervical cancer
Merck Inc., (known as MSD outside of the United States and Canada), announced that the European Commission (EC) has approved two new indications for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in gynecologic cancers
The first approval is for Keytruda, in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. The second approval is for Keytruda, in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. With these decisions, Keytrudas now approved for 30 indications in the EU, including five in gynecologic cancers – three in endometrial cancer and two in cervical cancer.
The EC approvals are based on results from the Phase III NRG-GY018 trial, also known as KEYNOTE-868, and the Phase III KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, respectively, and follow positive recommendations from the Committee for Medicinal Products for Human Use received in September 2024.
In NRG-GY018/KEYNOTE-868, Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone. In KEYNOTE-A18, Keytruda in combination with concurrent CRT demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and PFS compared to concurrent CRT alone for newly diagnosed patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer.
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