Sarclisa Recommended For EU Approval By The CHMP To Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma; Sarclisa Recommended For EU Approval By CHMP; Sarclisa Could Be First Anti-CD38 Therapy In EU For NDMM
Sarclisa Recommended For EU Approval By The CHMP To Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma; Sarclisa Recommended For EU Approval By CHMP; Sarclisa Could Be First Anti-CD38 Therapy In EU For NDMM
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa 建議歐盟批准 CHMP 批准用於治療不符合移植條件的新診斷多發性骨髓瘤
- Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with VRd significantly improved progression-free survival, compared to standard-of-care VRd alone
- If approved, Sarclisa would be the first anti-CD38 therapy in the EU available for use in combination with VRd for adult patients with transplant-ineligible NDMM
- 基於IMROZ 3期研究的建議，該研究表明，與單獨使用標準護理 vrD 相比，Sarclisa 與 vrD 聯合使用可顯著提高無進展存活率
- 如果獲得批准，Sarclisa將成爲歐盟第一種可與VrD聯合使用的抗CD38療法，適用於不符合移植條件的NDMM的成年患者
Paris, November 14, 2024. The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). A final decision is expected in the coming months.
巴黎，2024 年 11 月 14 日。歐洲藥品管理局（EMA）的人用藥品委員會（CHMP）已通過一項積極意見，建議批准Sarclisa與硼替佐米、來那度胺和地塞米松（vrD）聯合用於治療沒有資格進行自體幹細胞移植（ASCT）的新診斷多發性骨髓瘤（NDMM）的成年患者。最終決定預計將在未來幾個月內作出。
