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
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
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.
第一意見建議批准KEYTRUDA與卡鉑和紫杉醇聯合使用，隨後使用KEYTRUDA作爲單藥，用於初發性愛文思控股或複發性子宮內膜癌成年患者的一線治療，這些患者適合接受全身治療。
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.
第二個積極意見建議批准KEYTRUDA與化療放療（CRT）聯合用於尚未接受過準定療法的成年人治療FIGO（國際婦產科學聯合會）2014年第III-IVA期局部晚期宮頸癌。
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.
CHMP的建議現將由歐洲委員會審查，以在歐盟獲得上市授權，最終決定預計在2024年第四季度出臺。
譯文內容由第三人軟體翻譯。