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Merck's KEYTRUDA® (pembrolizumab) Secures 30th European Commission Approval with Two New Indications for Gynecologic Cancers

NextEdge Admin

25 Oct 2024

2 min 19 sec

European Commission,anti-PD-1 therapy,KEYTRUDA

Merck , known as MSD outside the U.S. and Canada, announced that the European Commission (EC) has approved two new indications for KEYTRUDA® (pembrolizumab), its anti-PD-1 therapy, in gynecologic cancers. The first approval covers KEYTRUDA in combination with carboplatin and paclitaxel for first-line treatment of primary advanced or recurrent endometrial carcinoma in adults eligible for systemic therapy. The second approval is for KEYTRUDA with concurrent chemoradiotherapy (CRT) to treat FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults without prior definitive therapy. With these approvals, KEYTRUDA is now authorized for 30 indications in the EU, including five in gynecologic cancers.

“These KEYTRUDA-based regimens can reshape the treatment landscape for endometrial and cervical cancers, two of the most common cancers among women in Europe,” said Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories.

The EC approvals are based on Phase 3 trials: NRG-GY018/KEYNOTE-868 and KEYNOTE-A18/ENGOT-cx11/GOG-3047. In NRG-GY018, the combination of KEYTRUDA with carboplatin and paclitaxel improved progression-free survival (PFS) significantly over chemotherapy alone. Similarly, the KEYNOTE-A18 trial showed that adding KEYTRUDA to CRT enhanced both overall survival (OS) and PFS compared to CRT alone.

These approvals apply across all 27 EU countries, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Availability in individual countries will depend on national reimbursement processes. KEYTRUDA has also been approved in the U.S. for similar indications based on these pivotal trials.