Merck Says European Medicines Agency's CHMP Adopted Positive Opinions Recommending Approval Of Keytruda (Pembrolizumab), Its Anti-PD-1 Therapy, For Two Indications In Gynecologic Cancers

Benzinga · Sep 20 19:31

The first opinion recommends the approval of KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy.

The second positive opinion recommends the approval of 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.

The CHMP's recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and final decisions are expected in the fourth quarter of 2024.

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Merck Says European Medicines Agency's CHMP Adopted Positive Opinions Recommending Approval Of Keytruda (Pembrolizumab), Its Anti-PD-1 Therapy, For Two Indications In Gynecologic Cancers

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