The Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Recommended Expanding The Approval Of GSK's Jemperli (Dostarlimab) In Combination With Chemotherapy (Carboplatin And Paclitaxel) For First-line Treatment For...

歐洲藥品管理局的人用藥品委員會已建議擴大對GSK的Jemperli（Dostarlimab）與化療（卡鉑和紫杉醇）聯合使用的批准，以作爲首線治療...

Benzinga · 2024/12/16 18:04

The Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Recommended Expanding The Approval Of GSK's Jemperli (Dostarlimab) In Combination With Chemotherapy (Carboplatin And Paclitaxel) For First-line Treatment For Primary Advanced Or Recurrent Endometrial Cancer Who Are Candidates For Systemic Therapy

歐洲藥品管理局的人用藥品委員會建議擴大對GSK的Jemperli（達斯特利普）的批准，以便與化療（卡鉑和紫杉醇）聯合使用，用於治療符合系統治療條件的原發性晚期或複發性子宮內膜癌的一線療法。

Positive opinion based on statistically significant and clinically meaningful progression-free and overall survival data from phase III RUBY trial.
An expanded approval would include MMRp/MSS tumours, which represent majority of endometrial cancer cases.
Approval decision expected in Q1 2025.

積極的意見基於來自第三階段RUBY試驗的統計學顯著和臨床有意義的無進展生存期和總體生存數據。
擴大的批准將包括MMRp/MSS腫瘤，這代表了大多數子宮內膜癌病例。
預計在2025年第一季度作出批准決定。

譯文內容由第三人軟體翻譯。

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