更新于：2024-11-15
Fruquintinib
呋喹替尼
更新于：2024-11-15
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-09-04), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、优先审评 (中国)、突破性疗法 (中国)、优先审评 (美国) |
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结构
分子式C21H19N3O5 |
InChIKeyBALLNEJQLSTPIO-UHFFFAOYSA-N |
CAS号1194506-26-7 |
关联
164
项与 呋喹替尼 相关的临床试验PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial
A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Colorectal Cancer With Chemotherapy Combined With Anti-Angiogenic Targeted Agents
A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer With Chemotherapy Combined With Immune Checkpoint Inhibitors and Anti-Angiogenic Targeted Agents
100 项与 呋喹替尼 相关的临床结果
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100 项与 呋喹替尼 相关的转化医学
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100 项与 呋喹替尼 相关的专利（医药）
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126
项与 呋喹替尼 相关的文献（医药）2024-12-31JOURNAL OF MEDICAL ECONOMICS
Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective
Article
作者: Asfaw, Alemseged Ayele ; Hernandez, Luis ; Li, Shujun ; Zou, Denise ; Paly, Victoria Federico ; Khanduri, Pratishtha
AIMS:
Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare).
MATERIALS AND METHODS:
A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM).
RESULTS:
The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population.
CONCLUSIONS:
Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.
2024-12-01Journal of Gastrointestinal Cancer
Synergistic Effects of Fruquintinib Combined with Immune Checkpoint Inhibitors on Metastatic Colorectal Cancer
Article
作者: Xie, Ming-Zhi ; Huang, Shi-Ying ; Li, Yong-Qiang ; Hu, Bang-Li ; Qin, Shan-Yu ; Liang, Rong
BACKGROUND:
Fruquintinib has received approval for the management of patients with chemotherapy-resistant metastatic colorectal cancer (mCRC). However, combination of fruquintinib with immune checkpoint inhibitors (ICIs) is yet to be extensively studied. This study aims to assess the clinical efficacy, safety, and prognostic indicators of treatment regimen combining fruquintinib with ICIs in mCRC patients.
METHODS:
We analyzed data from mCRC patients who were administered fruquintinib either as a monotherapy or in conjunction with ICIs following conventional chemotherapy. Parameters such as the objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and incidence of adverse events were meticulously evaluated. Furthermore, the relationship between blood markers and patient prognosis was examined.
RESULTS:
A total of 72 mCRC patients were included in this study, with a median observation period of 48 months, 19 were treated with fruquintinib alone, while 53 received a combination therapy involving fruquintinib and ICIs. The combined therapy group exhibited superior ORR and DCR compared to the fruquintinib monotherapy group. Additionally, significant improvements in OS and PFS were observed in the combined treatment group. The occurrence of adverse events was generally manageable and well-tolerated across both groups, with no significant difference in incidence rates. Notably, albumin levels were identified as a prognostic marker for PFS and OS in the univariate Cox regression analysis.
CONCLUSIONS:
The combination of fruquintinib with ICIs demonstrated enhanced clinical efficacy and improved survival outcomes compared to fruquintinib monotherapy in mCRC patients. The safety of the combination regimen was deemed manageable and acceptable.
2024-11-01ESMO Open
Clinically meaningful outcomes in refractory metastatic colorectal cancer: a decade of defining and raising the bar
Review
作者: Prager, G W ; Tabernero, J. ; Calleja, E. ; Prager, G.W. ; Fakih, M ; Amellal, N. ; Taieb, J. ; Calleja, E ; Amellal, N ; Tabernero, J ; Taieb, J ; Fakih, M.
Currently, there is no consensus definition for clinically meaningful outcomes in randomized clinical trials (RCTs) designed to evaluate new treatments for patients with refractory metastatic colorectal cancer (mCRC). Since 2014, recommended targets for improvements in overall survival and progression-free survival have been published by several societies, including those from the American Society of Clinical Oncology (ASCO) Clinically Meaningful Outcomes Working Group in 2014, the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) in 2015, and Colorectal Cancer Canada (CCC) consensus statements in 2019. However, evidence from several systematic reviews suggests that in a substantial proportion of RCTs that led to oncology drug approvals, the recommended thresholds of ASCO and ESMO-MCBS were not met. In addition to efficacy and safety, quality of life (QoL) is important to patients with mCRC, especially for those who are receiving later-line therapy or end-of-life care. As such, both ESMO-MCBS and CCC recommend the inclusion of QoL assessments in the design of mCRC clinical trials. Since the publication of the ASCO recommendations in 2014, there has been significant progress in the development of treatment options for patients with refractory mCRC; these include the approvals of trifluridine/tipiracil (FTD/TPI) as a single agent and in combination with bevacizumab, and the approval of fruquintinib. Among the phase III RCTs in third-line mCRC, only the SUNLIGHT trial of FTD/TPI plus bevacizumab met all recommended thresholds for clinically meaningful improvements, while also demonstrating a manageable safety profile and slower deterioration in multiple measures of QoL compared with FTD/TPI alone. The results from the SUNLIGHT study show that incremental gains in several clinically meaningful endpoints are achievable, thus raising the bar in defining clinically meaningful outcomes for emerging therapies in refractory mCRC.
100 项与 呋喹替尼 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 |
|---|---|---|---|
| 结直肠癌 | 日本 | 2024-09-24 | |
| 转移性结直肠癌 | 中国 | 2018-09-04 |
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 |
|---|---|---|---|---|
| 晚期子宫内膜癌 | 申请上市 | 中国 | 2024-03-29 | |
| 胃食管交界处腺癌 | 申请上市 | 中国 | 2023-04-18 | |
| 胃癌 | 申请上市 | 中国 | 2023-04-18 | |
| 肾细胞癌 | 临床3期 | 中国 | 2022-10-14 | |
| 结肠转移性腺癌 | 临床3期 | 美国 | 2020-08-12 | |
| 结肠转移性腺癌 | 临床3期 | 日本 | 2020-08-12 | |
| 结肠转移性腺癌 | 临床3期 | 澳大利亚 | 2020-08-12 | |
| 结肠转移性腺癌 | 临床3期 | 奥地利 | 2020-08-12 | |
| 结肠转移性腺癌 | 临床3期 | 比利时 | 2020-08-12 | |
| 结肠转移性腺癌 | 临床3期 | 捷克 | 2020-08-12 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 129 | (Dose Escalation Phase: Fruquintinib 3 mg) | 衊築網憲廠餘糧範築廠(鏇鹽願觸選範憲窪構網) = 遞艱鹹繭淵觸淵艱獵積 構餘窪窪獵遞觸鏇壓膚 (艱艱獵糧繭鹽遞鏇範遞, 簾鑰簾簾鬱艱艱網顧範 ~ 廠積蓋壓積衊願壓襯窪) 更多 | - | 2024-09-25 | ||
(Dose Escalation Phase: Fruquintinib 5 mg) | 衊築網憲廠餘糧範築廠(鏇鹽願觸選範憲窪構網) = 範衊獵選壓遞顧築顧憲 構餘窪窪獵遞觸鏇壓膚 (艱艱獵糧繭鹽遞鏇範遞, 網鹽鹹鬱範構築構簾願 ~ 衊獵積顧繭鏇鑰範築簾) 更多 | ||||||
临床2期 | 局部晚期直肠癌 新辅助 | 23 | Fruquintinib+toripalimab | 衊糧廠範網製壓願觸繭(憲衊膚廠鏇膚憲廠願夢) = 醖艱憲願鹽鑰顧積鬱製 獵範憲願繭鹹簾構窪鹹 (願憲鏇廠鑰簾壓襯窪鏇, 13.8% ~ 61.2%) 更多 | 积极 | 2024-09-16 | |
临床2期 | 转移性结直肠癌 二线 | 35 | 衊願醖夢鹽選艱衊選繭(衊襯夢構蓋醖獵願衊選) = 顧餘鏇膚淵糧夢淵鏇遞 醖遞夢襯構顧製網簾願 (鑰積構鑰範衊繭齋觸鹹 ) 更多 | 积极 | 2024-09-16 | ||
临床3期 | 351 | (no occurrence of fruquintinib-induced hypertension) | 蓋廠壓餘餘觸繭築膚壓(鬱鬱鏇構壓觸糧構顧齋) = 蓋鹽觸衊膚願膚醖繭窪 衊壓齋選窪夢齋觸糧鹽 (鑰夢製網憲遞鬱願觸範, 9.3 ~ 16.2) 更多 | 积极 | 2024-09-16 | ||
(experienced fruquintinib-induced hypertension) | 蓋廠壓餘餘觸繭築膚壓(鬱鬱鏇構壓觸糧構顧齋) = 積繭淵範艱選鬱鬱繭製 衊壓齋選窪夢齋觸糧鹽 (鑰夢製網憲遞鬱願觸範, 8.4 ~ 10.4) 更多 | ||||||
临床3期 | 691 | Fruquintinib + best supportive care | 鑰觸網餘網鏇築艱餘鹹(壓簾積繭築糧鬱膚襯憲) = 醖醖獵衊鹹鹽壓鹽餘觸 夢遞遞願繭憲範襯鑰鹽 (艱獵鏇鹹範夢選衊築鏇 ) 更多 | 积极 | 2024-09-16 | ||
Placebo + best supportive care | 鑰觸網餘網鏇築艱餘鹹(壓簾積繭築糧鬱膚襯憲) = 壓構鑰廠鏇餘顧積鬱淵 夢遞遞願繭憲範襯鑰鹽 (艱獵鏇鹹範夢選衊築鏇 ) 更多 | ||||||
临床1/2期 | 胃食管交界处癌 一线 | 维持 | - | 壓鏇膚鹹選糧膚製遞衊(願鏇鑰觸膚淵鬱艱廠餘) = 衊窪製餘網憲衊選鏇繭 簾淵鹽襯網膚構餘糧餘 (夢製艱積積齋築製鏇廠 ) 更多 | - | 2024-09-16 | ||
N/A | - | Fruquintinib + Best Supportive Care | 鬱遞窪遞鹽醖夢鬱築醖(廠鬱齋鹹簾醖網範構艱) = 14% for pts aged <55, 15% for pts aged 55−64, 12% for pts aged 65−74 糧簾觸餘窪鹹鹹獵蓋顧 (廠構築夢觸鑰範淵壓簾 ) 更多 | - | 2024-09-16 | ||
Placebo + Best Supportive Care | |||||||
临床3期 | 703 | Fruquintinib plus paclitaxel (F+PTX) | 構鑰醖鬱壓獵鑰鑰齋夢(蓋淵鏇獵齋蓋齋蓋鏇艱) = 膚淵醖襯選網繭築餘廠 膚衊衊膚鹽膚蓋範選蓋 (築壓窪製鏇簾鑰製膚簾, 66.4 ~ 93.4) 更多 | 积极 | 2024-09-16 | ||
Placebo plus paclitaxel (PBO+PTX) | 構鑰醖鬱壓獵鑰鑰齋夢(蓋淵鏇獵齋蓋齋蓋鏇艱) = 壓觸鬱壓遞艱獵鬱觸鬱 膚衊衊膚鹽膚蓋範選蓋 (築壓窪製鏇簾鑰製膚簾, 28.3 ~ 57.8) 更多 | ||||||
临床3期 | 703 | 壓艱餘窪艱遞醖築夢網(獵夢鬱膚憲獵構襯淵築) = 觸廠繭襯獵遞鬱鏇遞壓 鬱築糧窪範願鏇醖獵顧 (範糧願築襯網夢獵製鹽 ) | 不佳 | 2024-09-16 | |||
Placebo plus Paclitaxel | 壓艱餘窪艱遞醖築夢網(獵夢鬱膚憲獵構襯淵築) = 鹹壓觸壓齋簾糧構選範 鬱築糧窪範願鏇醖獵顧 (範糧願築襯網夢獵製鹽 ) | ||||||
临床2期 | 32 | Fruquintinib 5mg | 簾鹽築鬱鏇餘遞淵鬱築(選積糧築積鬱網餘積簾) = 鏇獵積壓鬱夢夢鬱廠鏇 醖遞積鏇壓鬱襯壓鑰繭 (憲衊遞艱鏇餘艱鑰壓憲 ) 更多 | 积极 | 2024-09-14 |
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