Merck announced on October 25, 2024, that the European Commission (EC) approved two new indications for KEYTRUDA (pembrolizumab) in gynecologic cancers. These approvals expand Keytruda's utility in Europe to 30 indications across 18 different cancer types.
The first approval is for Keytruda in combination with carboplatin and paclitaxel for the first-line treatment of primary advanced or recurrent endometrial carcinoma. The second is for Keytruda in combination with chemoradiotherapy for FIGO 2014 Stage III-IVA locally advanced cervical cancer.
These decisions are based on positive results from the Phase 3 NRG-GY018 and KEYNOTE-A18 trials, demonstrating statistically significant and clinically meaningful improvements in progression-free survival and overall survival. These approvals are expected to change treatment paradigms for women with these cancers in Europe.
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