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被欧洲药品管理局委员会(CHMP)推荐用于治疗不适合移植的新的多发性骨髓瘤；Sarclisa被CHMP推荐用于欧盟批准；Sarclisa可能成为欧盟首个针对新诊断多发性骨髓瘤的抗CD38疗法。
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa被CHMP推荐用于欧盟审批，治疗不适合移植的新诊断多发性骨髓瘤
- 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
- 该推荐基于IMROZ 3期研究，证明Sarclisa与VRd联合使用显著改善无进展生存期，相比于标准护理的VRd单独使用
- 如果获批，Sarclisa将成为欧盟首个可与VRd联合使用的抗CD38疗法，适用于不适合移植的成人新诊断多发性骨髓瘤患者
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。欧洲药品管理局（EMA）的人用药物委员会（CHMP）采纳了一项积极意见，推荐批准Sarclisa与博克替尼、来那度胺和地塞米松（VRd）联合使用，用于治疗不适合自体干细胞移植（ASCT）的新诊断多发性骨髓瘤（NDMM）成人患者。预计几个月内做出最终决定。
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