Novartis Scemblix Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML
Novartis Scemblix Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML
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Priority Review based on ASC4FIRST Phase III study with Scemblix data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard of care therapies (imatinib and 2G TKIs)1
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Treatment options combining high efficacy with safety and tolerability represent a critical gap in care for long-term CML management1
- Scemblix was previously granted FDA Breakthrough Therapy designation and is in review under the agency's Real-Time Oncology Review program2-4
- 基於ASC4FIRSt第三期研究的優先審查，Scemblix數據首次顯示與標準治療（伊馬替尼和2G TKIs）相比，具有明顯改善的分子反應和良好的安全性和耐受性特徵1。
- 將高療效與安全性和耐受性結合的治療選擇是慢性髓細胞白血病長期管理中的一個重要缺口1。
- Scemblix此前已獲得FDA突破性療法稱號，正在接受該機構的實時腫瘤學評審計劃2-4的審查。
East Hanover, July 29, 2024 – Novartis announced today that Scemblix (asciminib) has been granted Priority Review status by the US Food and Drug Administration (FDA) for treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP).
2024年7月29日，東漢諾威 - 諾華宣佈Scemblix（asciminib）因治療成人新診斷慢性期（Ph + CML-CP）費城染色體陽性慢性粒細胞白血病而獲得美國食品和藥物管理局（FDA）的優先審查地位。
The FDA grants Priority Review to medicines that address serious or life-threatening diseases or conditions and, if approved, would provide significant improvements in treatment safety or efficacy5. Scemblix previously received Breakthrough Therapy designation for the treatment of newly diagnosed adult patients and is currently being reviewed under the FDA's Real-Time Oncology Review (RTOR) program. Scemblix received Priority Review and Breakthrough Therapy designations at the time of the original new drug application for the treatment of adult patients with Ph+ CML-CP who have previously been treated with two or more TKIs2-4,6,7.
FDA授予針對嚴重或生命威脅性疾病或病情的藥物優先審查，並在獲批後將顯着提高治療的安全性或療效5。Scemblix此前已獲得突破性療法稱號，用於治療新診斷患者，並正在接受FDA的實時腫瘤學評審（RTOR）計劃的審查。Scemblix在最初的新藥申請時獲得了優先審查和突破性療法稱號，用於治療曾接受2個或2個以上TKIs治療的成人Ph + CML-CP患者2-4,6,7。