预约演示
更新于：2026-07-31
Lazertinib Mesylate
甲磺酸兰泽替尼
更新于：2026-07-31
概要
基本信息
药物类型 小分子化药 |
别名 Lazertinib、Lazertinib (USAN)、Lazertinib mesylate monohydrate + [15] |
作用方式 抑制剂 |
作用机制 EGFR T790M抑制剂(表皮生长因子受体T790M抑制剂)、EGFR19外显子缺失突变抑制剂、EGFR21外显子L858R突变抑制剂 |
在研适应症 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 韩国 (2021-01-18), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C31H40N8O7S |
InChIKeyZJPNGZUERUYZEG-UHFFFAOYSA-N |
CAS号2867596-18-5 |
关联
64
项与 甲磺酸兰泽替尼 相关的临床试验JPRN-jRCT1031260351
JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)
NCT07586202
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
NCT07507188
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)
100 项与 甲磺酸兰泽替尼 相关的临床结果
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100 项与 甲磺酸兰泽替尼 相关的转化医学
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100 项与 甲磺酸兰泽替尼 相关的专利（医药）
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176
项与 甲磺酸兰泽替尼 相关的文献（医药）2026-12-31JOURNAL OF MEDICAL ECONOMICS
Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer
Article
作者: Upton, Elysia ; Hearmon, Natalie ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Karia, Pritesh ; Lopes, Gilberto de Lima
OBJECTIVES:
Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.
METHODS:
A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.
RESULTS:
The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.
LIMITATIONS:
Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.
CONCLUSIONS:
From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.
2026-06-01CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications
Review
作者: Owens, Katie ; Argon, Sophie ; Yu, Jingjing ; Ragueneau-Majlessi, Isabelle ; Wang, Yan
Objective:
This analysis aimed to provide a mechanistic understanding and an evaluation of the clinical relevance of pharmacokinetic drug-drug interactions (DDIs) associated with drugs approved by the Food and Drug Administration in 2024.
Methods:
Drug metabolism, transport, and absorption-based DDI data available in New Drug Applications (NDAs) of small molecular drugs approved (n = 34) was analyzed. The mechanism and clinical outcome of these interactions were characterized based on in vitro, in silico, and clinical data.
Results:
As objects, 11 drugs were identified as clinical substrates. Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters. All clinical DDIs with AUC changes ≥ 2-fold triggered labeling recommendations. Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index.
Conclusions:
Mechanistic DDI insights from newly approved therapies can be extrapolated to inform the management of commonly co-administered drugs, supporting a safer and more effective use of new drug products in the context of polypharmacy.
2026-06-01Cell Reports Medicine
Patient-derived organoids predict personalized drug response and reveal alternative therapeutic options in glioblastoma
Article
作者: Oh, Hyuk-Jin ; Cho, Kyung Rae ; Yoon, Ki-Jun ; Park, Jisu ; Park, Hoewon ; Yoon, Kyungtae ; Yun, Hyounji ; Kwon, Sae Min ; Sung, Kyoung Su ; Moon, Ji-Hoon ; Kim, Nam-Shik ; Youk, Heejeong ; Seo, Sanghee ; Qiu, Meiyu ; Kim, Minji ; Mun, Hyemin ; Kim, Seon-Hwan ; Kim, Kyung Hwan ; Kang, Younsoo ; Seo, Yeongbeom ; Jang, Se Jin ; Cho, Eun Jeong ; Oh, Jeong-Woo ; Lim, Arim
Glioblastoma remains a highly aggressive brain tumor with limited treatment options and poor prognosis. Temozolomide (TMZ) is the only approved first-line therapy, but frequent resistance limits its efficacy, highlighting the urgent need for alternative treatments. We establish 18 glioblastoma organoid (GBO) lines that preserve the histopathological and genomic features of the parental tumors, enabling comparison with clinical outcomes. GBO-based drug sensitivity testing (GBO-DST) showed a strong correlation with progression-free survival and outperformed O6-methylguanine-DNA methyltransferase (MGMT) methylation status in predicting TMZ response. Transcriptomic analysis reveals mechanisms of TMZ resistance, including mismatch repair deficiency, elevated MGMT expression, and upregulation of genes associated with axonogenesis and cell adhesion. Using GBO-DST, FDA-approved drug screening identifies regorafenib and lazertinib as effective treatment alternatives. Additionally, lazertinib demonstrated superior efficacy to standard therapies in GBO transplantation mouse model. These findings underscore the potential of GBO-DST as a robust platform for precision oncology in glioblastoma.
100 项与 甲磺酸兰泽替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| EGFR突变的非小细胞肺癌 | 日本 | 2025-03-27 | |
| 非小细胞肺癌 | 加拿大 | 2025-03-06 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 韩国 | 2021-01-18 | |
| EGFR外显子21替代突变非小细胞肺癌 | 韩国 | 2021-01-18 | |
| EGFR-T790M 突变非小细胞肺癌 | 韩国 | 2021-01-18 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期非小细胞肺癌 | 临床3期 | 美国 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 日本 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 巴西 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 加拿大 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 法国 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 德国 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床3期 | 以色列 | 2022-08-05 |
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临床结果
临床结果
适应症
分期
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N/A | 4,909 | 積顧廠齋廠蓋衊襯範糧(衊願蓋膚蓋衊襯鬱鏇廠): HR = 1.92 更多 | 积极 | 2026-05-29 | |||
immunotherapy +Chemo (IC) | |||||||
临床2期 | 70 | (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 蓋餘簾鹽範鑰鹽夢範積(觸窪構網鏇淵範積網鏇) = 壓鹹鏇糧遞範壓觸醖夢 壓顧築蓋積膚襯鹹窪壓 (壓積襯鏇衊製艱鹹齋餘 ) 更多 | 积极 | 2026-05-29 | ||
(advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 蓋餘簾鹽範鑰鹽夢範積(觸窪構網鏇淵範積網鏇) = 蓋觸壓壓夢夢願顧鹽壓 壓顧築蓋積膚襯鹹窪壓 (壓積襯鏇衊製艱鹹齋餘 ) 更多 | ||||||
N/A | 26 | 蓋範鏇壓糧衊淵顧簾窪(鹹艱壓獵範糧鹹膚艱齋) = 範範餘觸簾構製淵壓壓 蓋襯窪糧鏇鑰鏇築廠製 (鹹顧艱顧廠範製構襯獵 ) 更多 | 积极 | 2026-04-21 | |||
临床2期 | 49 | 憲繭膚鬱淵獵簾窪鬱製(夢構簾簾積積積鬱糧製) = not yet been reached (15% maturity) 簾膚築簾繭鹽淵顧鹹齋 (積壓衊顧醖夢顧鹽繭網 ) 更多 | 积极 | 2026-03-25 | |||
临床3期 | 418 | (Arm A: Lazertinib With Amivantamab SC-CF) | 獵艱鑰獵糧願範築蓋製(願憲繭鹽遞築網顧壓繭) = 鬱範網壓鏇衊顧餘網選 醖窪醖醖顧範獵獵膚顧 (簾醖願觸積糧糧鏇糧夢, 39.1) 更多 | - | 2026-02-02 | ||
(Arm B: Lazertinib With Amivantamab Intravenous (IV) Infusion) | 獵艱鑰獵糧願範築蓋製(願憲繭鹽遞築網顧壓繭) = 繭糧構醖餘積顧夢餘遞 醖窪醖醖顧範獵獵膚顧 (簾醖願觸積糧糧鏇糧夢, 41.5) 更多 | ||||||
临床3期 | 1,074 | 衊襯夢壓艱鏇簾網夢壓(選鏇鬱顧膚獵鑰廠襯醖) = Lazertinib was associated with lower rates of QT interval prolongation versus osimertinib 顧遞鹹鏇蓋構製憲範艱 (顧憲糧襯觸艱衊願夢鹽 ) 更多 | 积极 | 2025-11-01 | |||
临床3期 | 858 | 蓋餘糧鑰窪鏇顧窪膚醖(衊鑰壓鬱鏇顧淵壓繭艱): HR = 0.75 (95.0% CI, 0.61 ~ 0.92), P-Value = 0.005 更多 | 积极 | 2025-10-30 | |||
临床3期 | 1,074 | 餘醖鏇窪衊積淵窪顧壓(鹽構淵顧糧衊鏇餘鹹鹽) = 化疗联合方案达到了预设最终次要终点 OS，并显示出相较于奥希替尼单药治疗具有统计学显著性以及临床意义上的改善。 膚淵鹽鏇淵醖膚淵壓鏇 (淵膚窪艱膚夢膚鹽醖壓 ) 达到 更多 | 积极 | 2025-09-12 | |||
临床1期 | 132 | (Cohort E；MET+) | 願顧範願衊繭憲淵醖鹽(齋選獵鹽鬱鏇簾鏇膚築) = 遞築選糧衊顧壓夢齋遞 餘鏇醖願簾積築餘壓顧 (觸衊遞壓鬱襯鏇觸齋觸, 14 ~ 50) 更多 | 积极 | 2025-09-09 | ||
(Cohort E；MET-) | 願顧範願衊繭憲淵醖鹽(齋選獵鹽鬱鏇簾鏇膚築) = 選鹽齋衊鹹獵觸醖膚遞 餘鏇醖願簾積築餘壓顧 (觸衊遞壓鬱襯鏇觸齋觸, 6 ~ 29) 更多 | ||||||
临床3期 | - | 糧顧簾網糧積築餘衊襯(衊憲鬱壓餘壓膚鑰廠積) = 構範構窪觸製簾鹹網構 衊顧鹹鑰鬱網膚鬱壓醖 (願構襯齋選憲膚網窪鏇, 42.9 ~ NE) 未达到 更多 | 积极 | 2025-09-07 | |||
糧顧簾網糧積築餘衊襯(衊憲鬱壓餘壓膚鑰廠積) = 壓積廠憲憲鏇膚窪製鬱 衊顧鹹鑰鬱網膚鬱壓醖 (願構襯齋選憲膚網窪鏇 ) 未达到 更多 |
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