德琪醫藥-B(06996.HK):新加坡HSA批准XPOVIO用於治療復發或難治性多發性骨髓瘤及瀰漫性大B細胞淋巴瘤三種適應症的新藥上市申請
格隆匯3月1日丨德琪醫藥-B(06996.HK)公吿,新加坡衞生科學局(HSA)已批准公司同類首款口服XPO1抑制劑,XPOVIO(塞利尼索)與硼替佐米和地塞米松聯用治療既往接受過至少一種療法的多發性骨髓瘤(MM)成人患者;與地塞米松聯用治療既往接受過至少四種療法且其疾病對至少兩種蛋白酶體抑制劑、至少兩種免疫調節劑及一種抗CD38單克隆抗體(五藥)難治的復發或難治性多發性骨髓瘤(rrMM)成人患者,以及作為單一療法治療既往接受過至少兩線治療、不符合造血幹細胞移植條件的復發╱難治性瀰漫大B細胞淋巴瘤(rrDLBCL)成人患者的新藥上市申請。
塞利尼索是目前首款且唯一一款被美國食品藥物管理局(FDA)批准的口服XPO1抑制劑。通過抑制核輸出蛋白XPO1,促使腫瘤抑制蛋白和其他生長調節蛋白的核內儲留和活化,並下調細胞漿內多種致癌蛋白水平,誘導腫瘤細胞凋亡,而正常細胞不受影響。基於其獨特的作用機制,塞利尼索正在被評估用於與其他多個藥物聯用以提高療效。
塞利尼索已獲得美國FDA批准用於治療復發╱難治性多發性骨髓瘤(rrMM)和復發╱難治性瀰漫性大B細胞淋巴瘤(rrDLBCL)。
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