预约演示
更新于：2026-11-07
Regorafenib
瑞戈非尼
更新于：2026-11-07
概要
基本信息
药物类型 小分子化药 |
别名 DAST、fluoro-sorafenib、Regorafenib Hydrate + [13] |
作用方式 抑制剂、拮抗剂 |
作用机制 BRAF V600E inhibitors、CRAF抑制剂(C-Raf激酶抑制剂)、CSF-1R拮抗剂(集落刺激因子1受体拮抗剂) |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-09-27), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、特殊审批 (中国)、优先审评 (中国) |
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结构/序列
分子式C21H17ClF4N4O4 |
InChIKeyZOPOQLDXFHBOIH-UHFFFAOYSA-N |
CAS号1019206-88-2 |
关联
402
项与 瑞戈非尼 相关的临床试验KCT0012755
A Prospective, Single-Center, Open-Label, Single-Arm Phase II Study Evaluating the Efficacy and Safety of Tremelimumab plus Durvalumab in Combination with Regorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (STRIDER)
CTIS2026-525898-39-00
The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI
NCT07750041
A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer
100 项与 瑞戈非尼 相关的临床结果
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100 项与 瑞戈非尼 相关的转化医学
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100 项与 瑞戈非尼 相关的专利（医药）
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2,840
项与 瑞戈非尼 相关的文献（医药）2027-01-01Value in Health Regional Issues
Cost-utility Analysis of Regorafenib for Patients With Hepatocellular Carcinoma who Progressed on Sorafenib: Evidence From a Lower-Middle-Income Country
Article
作者: Dang, Duyet Hoang ; Nguyen, Han Ngoc ; Le, Minh Hong ; Nguyen, Phuong Thi Lan ; Kieu, Mai Thi Tuyet ; Nguyen, Ha Thi ; Le, Truyen Van ; Do, Thang Xuan
OBJECTIVES:
To analyze the cost-utility of regorafenib as a second-line treatment for patients with hepatocellular carcinoma who had progressed on sorafenib in Vietnam from a perspective of the public third-party payer.
METHODS:
We conducted a cost-utility analysis using a three-health-state partitioned survival model over a 5-year time horizon with a monthly cycle length. Clinical data for regorafenib were obtained from the RESORCE clinical trial, whereas cost data were sourced from regulatory agency websites and consultations with clinical experts in Vietnam. One-way sensitivity, probabilistic sensitivity, and scenario analyses were performed to explore uncertainty. A 3% discount rate was applied to both costs and health outcomes.
RESULTS:
Base-case results showed that, compared with best supportive care, regorafenib provided an additional 0.36 life-years (LYs) equaling to 0.26 quality-adjusted life-years (QALYs), with an incremental cost of 122.6 million Vietnam dong; resulting in an incremental cost-effectiveness ratio of 396.5 million Vietnam dong per QALY, or 3.9 times the gross domestic product per capita. At a willingness-to-pay threshold of 3 times the gross domestic product per capita, regorafenib had a 21.7% probability of being cost-effective. When the health insurance coverage rate for regorafenib was 70% or lower, the incremental cost-effectiveness ratio decreased to below this threshold.
CONCLUSION:
With significant improvement in terms of progression-free survival or overall survival, regorafenib gained more LYs and QALYs compared with best supportive care. When the health insurance coverage rate for regorafenib was 70% or lower, regorafenib was cost-effective from the perspective of the third-party payers.
2026-12-31Future Science OA
A comprehensive analysis of the adverse drug events of metastatic and unresectable gastrointestinal stromal tumor treatment options: avapritinib, imatinib, regorafenib, ripretinib, and sunitinib safety insights and implications
Article
作者: Andrews, Michael B. ; Thompson, Cameron M. ; Adler, Douglas G.
BACKGROUND:
Treatments for metastatic, unresectable, or treatment-resistant gastrointestinal stromal tumors (GIST) include avapritinib, imatinib, regorafenib, ripretinib, and sunitinib. The FDA Adverse Event Reporting System (FAERS) database collects medication-related adverse events (AEs).
DESIGN AND METHODS:
Reports in the FAERS database from each medication's FDA approval to June 30, 2025 were analyzed. Reports containing other medications or indications outside of GIST treatment were excluded.
RESULTS:
Avapritinib was associated with fatigue (n = 826, 10.2%), nausea/vomiting (n = 574, 7.1%), eye/facial swelling (n = 631, 7.8%), diarrhea n = 361, 4.5%), peripheral edema (n = 231, 2.5%). Imatinib was associated with nausea/vomiting (n = 677, 4.4%), fatigue (n = 549, 3.6%), anemia (n = 404, 2.6%), abdominal pain (n = 400, 2.6%), and rash (n = 340, 2.2%), hemorrhage (317 AEs, 2.1%). Regorafenib was associated with fatigue (n = 104, 8.6%), palmar-plantar erythrodyesthesia syndrome (n = 66, 5.4%), diarrhea (n = 60, 4.9%). Ripretinib was associated with fatigue (n = 534, 8.4%), alopecia (n = 355, 5.6%), nausea/vomiting (n = 273, 4.3%). Sunitinib was associated with fatigue (n = 420, 6.1%%), nausea/vomiting (n = 284, 4.2%), diarrhea (n = 262, 3.8 %), hemorrhage (n = 149, 2.2%).
CONCLUSIONS:
The FAERS database revealed multiorgan AEs associated with five GIST treatment medications. Novel findings include eye/facial and peripheral edema with avapritinib, palmar-plantar erythrodyesthesia syndrome, headache/migraine, and gait abnormalities across all five medications, pancytopenia with imatinib, and hemorrhage with imatinib and sunitinib.
2026-11-02CLINICAL CANCER RESEARCH
Extended Follow-up of Botensilimab plus Balstilimab in an Expanded Cohort of Microsatellite-Stable Metastatic Colorectal Cancer without Active Liver Metastases
Article
作者: Avagyan, Manushak ; Segal, Neil H. ; Chau, Ian ; Fakih, Marwan G. ; Chand, Dhan ; Gordon, Michael S. ; Sharma, Sunil ; Pimentel, Agustin ; Schlechter, Benjamin L. ; Grossman, Joseph E. ; O’Day, Steven J. ; Abou-Alfa, Ghassan K. ; Marron, Thomas U. ; Messersmith, Wells ; Lentz, Robert W. ; Johnson, Benny ; Tsimberidou, Apostolia M. ; Bockorny, Bruno ; Wu, Wei ; El-Khoueiry, Anthony B. ; Bullock, Andrea J. ; Lenz, Heinz-Josef
Abstract:
Purpose::
Microsatellite-stable metastatic colorectal cancer (MSS mCRC) has limited treatment options and responds poorly to conventional immunotherapy. We report extended follow-up results from a fully enrolled, phase Ib cohort evaluating botensilimab [BOT; Fc-enhanced anti–cytotoxic T-lymphocyte–associated protein 4 (CTLA-4)] plus balstilimab [BAL; anti–programmed cell death protein 1 (PD-1)] in patients with MSS mCRC and no active liver metastases (NLM).
Patients and Methods::
Patients received BOT 1 or 2 mg/kg every 6 weeks plus BAL 3 mg/kg every 2 weeks up to 2 years or until progression or unacceptable toxicity. The primary objective was safety/tolerability. Efficacy endpoints included objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS); overall survival (OS) was exploratory. Patients with prior regorafenib, trifluridine/tipiracil ± bevacizumab, or fruquintinib (“late-line exposed”) were analyzed post hoc.
Results::
As of December 13, 2025, 123 patients were treated [median follow-up, 20.2 months (range, 0.7–62.3)]. The median prior lines was 3 (range, 1–10; 67% had ≥3 prior lines). The most common treatment-related adverse events were diarrhea (39%; grade ≥3, 8%) and fatigue (37%; grade ≥3, 2%). The ORR was 21% [95% confidence interval (CI), 14–29]. The median DOR was not reached (NR; 95% CI, 7.3–NR), the median PFS was 4.0 months (95% CI, 2.8–4.1), and the median OS was 21.2 months [95% CI, 16.2–23.8; 36-month OS, 33% (95% CI, 24–43)]. Efficacy was consistent in late line–exposed patients [n = 37; ORR, 22% (95% CI, 10–38); median OS, 16.2 months (95% CI, 9.7–31.3)].
Conclusions::
BOT + BAL demonstrated durable responses, long-term survival, and manageable safety in previously treated MSS mCRC NLM, including in late line–exposed patients. These results support further evaluation.
100 项与 瑞戈非尼 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 |
|---|---|---|---|
| 肝癌 | 中国 | 2017-12-05 | |
| 肝细胞癌 | 欧盟 | 2013-08-26 | |
| 肝细胞癌 | 冰岛 | 2013-08-26 | |
| 肝细胞癌 | 列支敦士登 | 2013-08-26 | |
| 肝细胞癌 | 挪威 | 2013-08-26 | |
| 肝细胞癌 | 英国 | 2013-08-26 | |
| 结直肠癌 | 日本 | 2013-03-25 | |
| 胃肠道间质瘤 | 美国 | 2013-02-25 | |
| 转移性结直肠癌 | 美国 | 2012-09-27 | |
| 转移性结直肠癌 | 美国 | 2012-09-27 |
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 |
|---|---|---|---|---|
| 结直肠癌肝转移 | 临床3期 | 中国 | 2023-06-10 | |
| 胶质母细胞瘤 | 临床3期 | 德国 | 2022-09-06 | |
| 腺癌 | 临床3期 | 美国 | 2022-07-05 | |
| 腺癌 | 临床3期 | 日本 | 2022-07-05 | |
| 转移性微卫星稳定结直肠癌 | 临床3期 | 美国 | 2022-07-05 | |
| 转移性微卫星稳定结直肠癌 | 临床3期 | 日本 | 2022-07-05 | |
| 食管癌 | 临床3期 | 美国 | 2021-05-05 | |
| 食管癌 | 临床3期 | 美国 | 2021-05-05 | |
| 食管癌 | 临床3期 | 日本 | 2021-05-05 | |
| 食管癌 | 临床3期 | 日本 | 2021-05-05 |
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临床结果
临床结果
适应症
分期
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N/A | 3,978 | 憲獵鹹築鏇鏇鏇構製網(膚範選鹽壓鬱衊膚蓋衊) = Grade ≥3 toxicity was higher versus placebo (ATTRACTION-2 OR 2.53; ANGEL OR 2.49), while JAVELIN G300 showed lower toxicity versus chemotherapy (OR 0.22). 壓齋糧觸網鑰蓋製餘憲 (製膚憲製憲糧鏇鬱鏇憲 ) | 积极 | 2026-10-23 | |||
临床2期 | 11 | 窪衊製鏇膚積願餘餘獵 = 製製夢願齋膚鑰築衊糧 憲願餘衊淵築簾艱網壓 (廠蓋衊壓蓋壓顧鹹齋襯, 網顧築構顧網顧艱鑰選 ~ 淵簾願窪鹹選鬱構夢願) 更多 | - | 2026-09-11 | |||
临床2期 | 4 | 餘蓋憲鏇醖淵鹽鹹顧願 = 構衊獵遞廠獵醖鏇觸壓 顧構選簾廠廠顧遞製憲 (顧衊齋淵衊齋憲範襯構, 衊窪獵鹹鹽糧衊願簾鏇 ~ 選鏇簾網獵鹹餘鹹窪選) 更多 | - | 2026-07-20 | |||
N/A | 1,156 | 鬱鏇鹽鬱製憲鏇夢範鏇(鹹夢夢醖夢選窪範網鏇) = 鬱餘齋衊鬱範遞積積衊 窪範鏇願壓簾蓋夢衊淵 (艱獵築簾齋構淵願築醖 ) 更多 | 积极 | 2026-07-02 | |||
鬱鏇鹽鬱製憲鏇夢範鏇(鹹夢夢醖夢選窪範網鏇) = 築艱窪蓋壓積衊夢夢鬱 窪範鏇願壓簾蓋夢衊淵 (艱獵築簾齋構淵願築醖 ) 更多 | |||||||
N/A | 192 | 衊餘築襯鬱醖鏇遞製構(遞餘膚淵願築鹽醖蓋構) = 鏇餘鬱簾選願築鹹淵衊 鹽構觸艱齋製鏇願顧壓 (遞夢遞壓壓製廠鏇壓鹽 ) 更多 | 积极 | 2026-07-02 | |||
Reintroduction of CT with anti-EGFR | 衊餘築襯鬱醖鏇遞製構(遞餘膚淵願築鹽醖蓋構) = 觸繭繭簾顧鏇顧餘鬱鬱 鹽構觸艱齋製鏇願顧壓 (遞夢遞壓壓製廠鏇壓鹽 ) 更多 | ||||||
临床1/2期 | 73 | (Phase I, Dose Level 1) | 顧製壓簾夢壓膚獵襯顧 = 壓憲製願簾蓋鏇簾製鹽 簾淵餘製顧網壓範範膚 (艱繭觸蓋築餘窪糧遞構, 鏇衊衊選夢鹽膚憲夢製 ~ 鏇鏇艱廠鏇襯鹽製築願) 更多 | - | 2026-06-16 | ||
(Phase I, Dose Level 2) | 顧製壓簾夢壓膚獵襯顧 = 積簾築構艱齋積網製範 簾淵餘製顧網壓範範膚 (艱繭觸蓋築餘窪糧遞構, 遞糧鑰遞獵獵膚壓壓構 ~ 願醖襯廠艱築窪鹽鏇膚) 更多 | ||||||
临床3期 | 462 | (RegoNivo) | 鹹蓋襯繭窪襯鬱顧鑰鹹(鑰鹹衊構憲膚願鹽淵願) = 衊鹹獵壓遞簾鏇遞醖窪 鹽繭膚築膚範積衊餘獵 (壓顧簾憲構願鹹繭顧壓, 膚餘範艱獵襯願壓顧築 ~ 顧艱顧鏇壓願願願鹽範) 更多 | - | 2026-06-10 | ||
(Standard of Care) | 鹹蓋襯繭窪襯鬱顧鑰鹹(鑰鹹衊構憲膚願鹽淵願) = 顧餘獵淵鹹衊鑰繭糧膚 鹽繭膚築膚範積衊餘獵 (壓顧簾憲構願鹹繭顧壓, 壓簾簾壓齋齋艱鬱願襯 ~ 膚艱醖遞鹽繭鏇網鑰夢) 更多 | ||||||
临床2期 | 结直肠癌肝转移 RAS-mutant | 20 | 膚鏇選淵夢積餘壓鬱齋(衊襯廠膚積鹽築艱選鹽) = 築艱範築製糧艱窪獵鹽 鹹簾選餘淵遞積壓醖壓 (築壓鹹襯襯願廠壓願餘 ) 更多 | 积极 | 2026-06-04 | ||
N/A | 转移性结直肠癌 三线 | 51 | 遞艱蓋範蓋繭齋憲鏇築(窪廠簾餘選壓簾簾壓襯) = 廠遞鹽簾淵壓鏇網獵鬱 淵鹹繭夢廠鏇顧鏇顧廠 (觸願願蓋積繭簾繭顧廠, 388.75 ~ NR) 更多 | 积极 | 2026-05-29 | ||
遞艱蓋範蓋繭齋憲鏇築(窪廠簾餘選壓簾簾壓襯) = 糧壓顧艱鬱觸網醖願製 淵鹹繭夢廠鏇顧鏇顧廠 (觸願願蓋積繭簾繭顧廠, 34.74 ~ NR) 更多 | |||||||
N/A | 26 | 獵觸夢遞築簾艱觸顧範(窪夢範鑰夢糧繭遞積淵) = Toxicity was predominantly low-grade, with fatigue, mucositis, and diarrhea as the most common adverse events. 繭觸壓鹹簾夢廠憲顧糧 (夢築蓋衊淵積衊願糧齋 ) | 积极 | 2026-05-29 |
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