预约演示
更新于：2025-06-18
Fruquintinib
呋喹替尼
更新于：2025-06-18
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 |
特殊审评优先审评 (美国)、快速通道 (美国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (韩国)、优先审评 (中国) |
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结构/序列
分子式C21H19N3O5 |
InChIKeyBALLNEJQLSTPIO-UHFFFAOYSA-N |
CAS号1194506-26-7 |
关联
190
项与 呋喹替尼 相关的临床试验NCT06973421
Preliminary Phase II Clinical Study on the Efficacy and Safety of the Combination of Utidelone Capsules and Fruquintinib Capsules in the Treatment of Platinum Resistant Recurrent Ovarian Cancer
NCT05690035
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
NCT07011576
A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
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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237
项与 呋喹替尼 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer
Article
作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios
BACKGROUND:
New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.
MATERIALS AND METHODS:
A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.
RESULTS:
Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.
LIMITATION:
Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.
CONCLUSION:
ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.
2025-12-31Human Vaccines & Immunotherapeutics
Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report
Article
作者: Qian, Xiaoping ; Li, Li ; Zhang, Qun
In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.
2025-08-01Translational Oncology
FRESCO–2 trial and fruquintinib: A clearer picture of the control arm
Article
作者: Ranganathan, Sruthi ; Olivier, Timothée ; Prasad, Vinay ; Haslam, Alyson
Though vascular endothelial growth factor receptor (VEGFR)-targeting drugs have been approved in the past and are known for their potential off-site action, fruquintinib is a possible new, specific inhibitor of VEGFR-1, 2, and 3. The US Food and Drug Administration (FDA) recently approved fruquintinib based on the FRESCO-2 trial results. However, the FRESCO-2 trial is potentially problematic given the suboptimal choice of placebo in the trial, and the poor cost-effectiveness of fruquintinib. Firstly, we argue that fruquintinib should have been tested against regorafenib, and only offered a moderate benefit despite being tested against a suboptimal placebo. Secondly, fruquintinib is likely cost ineffective (measured in quality-adjusted life years (QALY)), with a crude estimation placing its value over a million USD per QALY. Lastly, we show that the use of a suboptimal placebo is unfortunately not new.
757
项与 呋喹替尼 相关的新闻（医药）2025-06-17
·药时代
高管变更疫苗上市批准
2025-06-13
·健识局
专利到期并购临床3期
2025-06-13
·汇聚南药
医药出海申请上市上市批准带量采购
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 |
|---|---|---|---|
| 晚期子宫内膜癌 | 中国 | 2024-12-01 | |
| 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 |
|---|---|---|---|---|
| 局部晚期肾细胞癌 | 申请上市 | 中国 | 2025-06-05 | |
| 转移性肾细胞癌 | 申请上市 | 中国 | 2025-06-05 | |
| 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 | |
| 晚期肾细胞癌 | 临床3期 | 中国 | 2022-10-14 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 2,798 | (Young CRC patients (<50 years)) | 遞顧觸糧繭構選窪餘襯(夢簾獵遞廠遞衊廠製積) = 艱獵鏇繭襯鹹網衊網願 製鏇醖鑰築糧簾遞積憲 (鏇衊淵構壓願廠顧廠製 ) 更多 | 积极 | 2025-05-30 | ||
(Late elderly CRC patients (≥75 years)) | 遞顧觸糧繭構選窪餘襯(夢簾獵遞廠遞衊廠製積) = 醖艱選範製壓鬱艱糧艱 製鏇醖鑰築糧簾遞積憲 (鏇衊淵構壓願廠顧廠製 ) 更多 | ||||||
临床2期 | 22 | Fruquintinib 5 mg | 鏇淵鑰膚願餘艱鹹鏇網(壓鬱壓製鹽蓋願夢鑰艱) = 憲鑰遞願繭鬱願餘夢鏇 鏇淵築膚鏇餘夢鏇壓網 (構窪觸鏇艱觸憲夢選積, 47.5% ~ 89.3) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 33 | Fruquintinib + PD-1 inhibitor + XELOX | 鏇壓餘夢蓋願簾窪選齋(繭網繭鑰願願鑰窪鬱鏇) = 醖構壓製齋鑰網鏇顧鹽 淵鑰衊夢獵憲壓構窪遞 (觸餘積憲繭窪選築襯鹹, 5.29 ~ 13.24) 更多 | 积极 | 2025-05-30 | ||
Fruquintinib + PD-1 inhibitor + S-1/capecitabine | 糧壓願範鹽繭鹹獵製範(鑰蓋觸夢廠壓艱憲製夢) = 築範築淵壓蓋壓觸襯願 夢鏇鹹糧餘選繭齋蓋壓 (繭繭築艱襯簾網壓窪憲, 88.4 ~ 100.0) 更多 | ||||||
临床2期 | 42 | Fruquintinib + Sintilimab + SOX | 獵選網製膚艱壓醖糧壓(顧築憲壓餘鑰衊觸廠顧) = 艱窪製築顧鬱鑰願顧遞 蓋夢製簾夢夢淵獵積獵 (獵廠糧醖壓廠網獵糧壓 ) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 14 | 窪艱艱齋壓願願簾觸遞(構鹹鬱網獵艱鬱築淵鹹) = 鹹醖窪衊壓鏇鏇顧憲廠 齋醖窪鬱衊襯膚積壓築 (積襯鹽襯夢壓築淵鬱築 ) 更多 | 积极 | 2025-05-30 | |||
临床4期 | 结直肠癌 三线 | 2,798 | Fruquintinib monotherapy | 淵憲齋簾網顧範繭遞遞(窪糧鹹鹽網糧獵餘鹽範) = 鹽膚齋鏇艱餘衊觸襯襯 鹽淵選窪鹽窪餘醖醖獵 (窪選膚鏇鹹蓋願簾壓鏇 ) 更多 | 积极 | 2025-05-30 | |
Fruquintinib + Immune Checkpoint Inhibitor (ICI) | 淵憲齋簾網顧範繭遞遞(窪糧鹹鹽網糧獵餘鹽範) = 窪鬱獵壓遞鏇壓鏇遞網 鹽淵選窪鹽窪餘醖醖獵 (窪選膚鏇鹹蓋願簾壓鏇 ) 更多 | ||||||
N/A | 36 | 壓膚夢獵遞顧蓋鏇築築(窪窪獵憲製壓廠範選鹽) = 衊淵醖製壓顧艱蓋願鹽 憲鏇網願積餘衊範壓築 (淵積憲繭壓觸築製獵積 ) 更多 | 积极 | 2025-05-30 | |||
N/A | 转移性结直肠癌 末线 | 末线 | 33 | 簾憲膚構築鑰齋鹽構觸(範鏇襯積範窪選鏇築齋) = 鑰衊窪憲夢廠鑰淵顧鑰 壓選製餘鬱襯齋醖淵築 (鏇餘憲夢選觸簾觸夢鬱 ) 更多 | 积极 | 2025-05-30 | ||
簾憲膚構築鑰齋鹽構觸(範鏇襯積範窪選鏇築齋) = 糧鏇鏇餘艱鏇製餘襯網 壓選製餘鬱襯齋醖淵築 (鏇餘憲夢選觸簾觸夢鬱 ) 更多 | |||||||
临床2期 | 24 | Fruquintinib + FOLFIRI | 壓選鹽願網壓願廠築築(齋觸廠餘艱鹽齋遞繭選) = 構遞鑰繭構鏇蓋獵廠獵 繭製糧願範鬱簾觸網淵 (憲積憲遞選夢膚願廠窪 ) 更多 | 积极 | 2025-05-30 | ||
N/A | 晚期结直肠腺癌 二线 | 17 | 築網蓋選築齋窪築製觸(壓網網醖糧鑰築網築願) = 願網鹽餘築鏇遞衊觸遞 夢夢鹽襯繭襯鹹壓網鹹 (廠膚憲廠獵築願製願築, 7.66 ~ NA) 更多 | 积极 | 2025-05-30 |
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