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6-K: Novartis Scemblix® FDA Approved in Newly Diagnosed CML

6-K: Novartis Scemblix® FDA Approved in Newly Diagnosed CML

6-K:诺华 Scemblix® 已获 FDA 批准用于新诊断的 CML
美股SEC公告 ·  2024/10/29 20:11

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Novartis announced FDA accelerated approval of Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The approval is based on the Phase III ASC4FIRST trial showing superior efficacy versus all standard of care therapies.The trial demonstrated that 68% of Scemblix-treated patients achieved major molecular response (MMR) versus 49% for standard therapies at week 48. Scemblix showed a favorable safety profile with fewer treatment-related grade ≥3 adverse reactions (25.5% vs. 33%), lower dose reductions (6% vs. 14%), and half the discontinuation rate (4.5% vs. 11%) compared to standard treatments.The expanded indication increases the eligible patient population by approximately four times. The approval addresses an important unmet need, as nearly 50% of CML patients do not meet efficacy milestones and almost 25% discontinue or switch treatments within one year. The ASC4FIRST trial continues with next analysis scheduled at week 96.
Novartis announced FDA accelerated approval of Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The approval is based on the Phase III ASC4FIRST trial showing superior efficacy versus all standard of care therapies.The trial demonstrated that 68% of Scemblix-treated patients achieved major molecular response (MMR) versus 49% for standard therapies at week 48. Scemblix showed a favorable safety profile with fewer treatment-related grade ≥3 adverse reactions (25.5% vs. 33%), lower dose reductions (6% vs. 14%), and half the discontinuation rate (4.5% vs. 11%) compared to standard treatments.The expanded indication increases the eligible patient population by approximately four times. The approval addresses an important unmet need, as nearly 50% of CML patients do not meet efficacy milestones and almost 25% discontinue or switch treatments within one year. The ASC4FIRST trial continues with next analysis scheduled at week 96.
诺华公司宣布,FDA加速批准Scemblix(阿司米尼布)用于新诊断的成人费城染色体阳性慢性髓性白血病慢性期患者(Ph+ CML-CP)。该批准基于III期ASC4FIRSt试验,其结果显示与所有标准治疗相比,该药具有更优的疗效。试验表明,68%的Scemblix治疗患者在第48周达到了主要分子反应(MMR),而标准治疗为49%。与标准治疗相比,Scemblix显示出良好的安全性特征,治疗相关的≥3级不良反应发生率更低(25.5%对33%)、剂量减少比例更低(6%对14%),且停药率也只有一半(4.5%对11%)。扩展适应症使符合资格的患者人数增加了大约四倍。该批准解决了一个重要的未满足需求,因为将近50%的CML患者未能达到疗效里程碑,而几乎25%的患者在一年内停药或更换治疗。ASC4FIRSt试验将继续进行,下一次分析计划在第96周进行。
诺华公司宣布,FDA加速批准Scemblix(阿司米尼布)用于新诊断的成人费城染色体阳性慢性髓性白血病慢性期患者(Ph+ CML-CP)。该批准基于III期ASC4FIRSt试验,其结果显示与所有标准治疗相比,该药具有更优的疗效。试验表明,68%的Scemblix治疗患者在第48周达到了主要分子反应(MMR),而标准治疗为49%。与标准治疗相比,Scemblix显示出良好的安全性特征,治疗相关的≥3级不良反应发生率更低(25.5%对33%)、剂量减少比例更低(6%对14%),且停药率也只有一半(4.5%对11%)。扩展适应症使符合资格的患者人数增加了大约四倍。该批准解决了一个重要的未满足需求,因为将近50%的CML患者未能达到疗效里程碑,而几乎25%的患者在一年内停药或更换治疗。ASC4FIRSt试验将继续进行,下一次分析计划在第96周进行。
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