Merck’s KEYTRUDA Receives 30th European Approval for Gynecologic Cancers

Approval Milestone:
Merck's KEYTRUDA (pembrolizumab) has received its 30th approval from the European Commission, marking two new indications in gynecologic cancers.

Indications:
KEYTRUDA is now approved for use in combination with chemotherapy for primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status, and in combination with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA locally advanced cervical cancer.

Clinical Trials:
The approvals are based on results from the Phase 3 NRG-GY018 (KEYNOTE-868) and KEYNOTE-A18 trials, which demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone or concurrent chemoradiotherapy alone.

Market Availability:
These approvals allow for the marketing of these KEYTRUDA regimens in all 27 EU member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland, with commercial availability dependent on national reimbursement procedures.

Impact:
These KEYTRUDA-based regimens have the potential to transform the treatment landscape for endometrial and cervical cancers, two of the most commonly diagnosed cancers among women in Europe.