-- 葛蘭素史克（GSK.L）宣布，其藥物Blenrep已獲得中國國家藥品監督管理局的批准，為復發或難治性多發性骨髓瘤患者提供了一種新的治療選擇，以應對中國持續上升的多發性骨髓瘤病例。 這家生物製藥公司在周一提交的文件中指出，中國的多發性骨髓瘤病例已翻了一番，達到每年3萬例，死亡率在過去30年中上升了50%。在全球範圍內，這種「可治療但無法治癒」的疾病被認為是第三大常見血液癌症，每年新增病例達18萬例。 經中國監管機構優先審查後，這種單株抗體藥物偶聯物獲準與硼替佐米和地塞米松合併使用，用於治療至少接受過一線治療的成年患者。 此次批准基於Dreamm-7 III期研究的數據，結果顯示，與基於達雷妥尤單抗（daratumumab）的三聯療法（硼替佐米和地塞米松）相比，Blenrep方案在無進展生存期（PFS）和總生存期（OS）方面取得了「具有統計意義和臨床意義」的顯著療效。此外，Blenrep合併療法與各成分藥物已記錄的安全性特徵保持一致。 「Blenrep的核准為中國復發或難治性多發性骨髓瘤二線及以上患者帶來了抗B細胞成熟抗原（BCMA）療法，其獨特的作用機制有望延緩疾病進展並延長生存期。此外，作為目前唯一獲批的抗BCMA抗體偶聯藥物（ADC），Blenrep可完全在門診給藥，因此患者無需複雜的給藥前準備或住院治療，即可在任何醫療機構接受治療。 Abdullah表示。 Blenrep已獲得超過15項國際授權，是多發性骨髓瘤二線及以上治療方案的成熟療法，已在包括歐盟、英國和日本在內的多個市場獲批。核准的合併用藥方案包括地塞米松合併硼替佐米或泊馬度胺。 葛蘭素史克在倫敦上市的股票週一午盤交易時段小幅下跌。
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