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
- 基于ASC4FIRSt第三期研究的优先审查，Scemblix数据首次显示与标准治疗（伊马替尼和2G TKIs）相比，具有明显改善的分子反应和良好的安全性和耐受性特征1。
- 将高疗效与安全性和耐受性结合的治疗选择是慢性髓细胞白血病长期管理中的一个重要缺口1。
- Scemblix此前已获得FDA突破性疗法称号，正在接受该机构的实时肿瘤学评审计划2-4的审查。
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，东汉诺威 - 诺华宣布Scemblix（asciminib）因治疗成人新诊断慢性期（Ph + CML-CP）费城染色体阳性慢性粒细胞白血病而获得美国食品和药物管理局（FDA）的优先审查地位。
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授予针对严重或生命威胁性疾病或病情的药物优先审查，并在获批后将显着提高治疗的安全性或疗效5。Scemblix此前已获得突破性疗法称号，用于治疗新诊断患者，并正在接受FDA的实时肿瘤学评审（RTOR）计划的审查。Scemblix在最初的新药申请时获得了优先审查和突破性疗法称号，用于治疗曾接受2个或2个以上TKIs治疗的成人Ph + CML-CP患者2-4,6,7。