预约演示
更新于：2025-08-13
Famitinib Malate
苹果酸法米替尼
更新于：2025-08-13
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国)、附条件批准 (中国) |
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结构/序列
分子式C27H33FN4O7 |
InChIKeyJNDRBKCNKMZANY-QLTVYZEUSA-N |
CAS号1256377-67-9 |
关联
87
项与 苹果酸法米替尼 相关的临床试验NCT06913777
An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer
ChiCTR2500096838
Efficacy and safety of famitinib in the treatment of unresectable advanced desmoid tumors: a prospective, single-arm clinical study
ChiCTR2400095075
Adebrelimab combined with famitinib as third-line or beyond treatment for soft tissue sarcoma: a multicenter, parallel cohort, phase ? clinical study
100 项与 苹果酸法米替尼 相关的临床结果
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100 项与 苹果酸法米替尼 相关的转化医学
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100 项与 苹果酸法米替尼 相关的专利（医药）
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115
项与 苹果酸法米替尼 相关的文献（医药）2025-07-17Pharmaceutics
Tyrosine Kinase Inhibitors for Gastrointestinal Stromal Tumor After Imatinib Resistance.
Review
作者: Zhang, Yin-Xu ; Song, He ; Hu, Ji-Yuan ; Zhang, Qian-Shi ; Xiao, Xian-Hao
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract, primarily driven by activating mutations in KIT (CD117) and platelet-derived growth factor receptor alpha (PDGFRA). The introduction of tyrosine kinase inhibitors (TKIs), especially imatinib, has significantly transformed GIST treatment. However, the emergence of both primary and secondary resistance to imatinib presents ongoing therapeutic challenges. This review comprehensively explores the mechanisms underlying imatinib resistance and evaluates subsequent TKI therapies. Sunitinib, regorafenib, and ripretinib are currently approved as standard second-, third-, and fourth-line therapies, each demonstrating efficacy against distinct mutational profiles. Avapritinib, notably effective against PDGFRA D842V mutations, represents a milestone for previously untreatable subgroups. Several alternative agents-such as nilotinib, masitinib, sorafenib, dovitinib, pazopanib, and ponatinib-have shown varying degrees of success in refractory cases or specific genotypes. Investigational compounds, including crenolanib, bezuclastinib, famitinib, motesanib, midostaurin, IDRX-42, and olverembatinib, are under development to address resistant or wild-type GISTs. Despite progress, long-term efficacy remains limited due to evolving resistance. Future strategies include precision medicine approaches such as ctDNA-guided therapy, rational drug combinations, and novel drug delivery systems to optimize bioavailability and reduce toxicity. Ongoing research will be crucial for refining treatment sequencing and expanding therapeutic options, especially for rare GIST subtypes.
2025-01-01The Innovation
Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study
Article
作者: Yang, Mudan ; Qu, Song ; Yu, Yiyi ; Zhang, Shilong ; Xiu, Peng ; Yang, Xinfeng ; Cheng, Ying ; Pan, Yueyin ; Lu, Jin ; Yuan, Ying ; Wang, Xicheng ; Gao, Shegan ; Feng, Jifeng ; Zhang, Xizhi ; Ai, Luoyan ; Liu, Tianshu ; Li, Jin ; Yi, Shanyong ; Dong, Yu ; Li, Qian ; Wang, Shuni ; Wang, Junsheng
Concurrent inhibition of angiogenesis and immune checkpoints represents a potent therapeutic approach. We conducted a phase 2, multicenter, basket study to assess the efficacy and safety of combination therapy of famitinib (anti-angiogenic agent) plus camrelizumab (PD-1 antagonist) in patients with metastatic solid tumors across 11 cohorts (this study was registered at Clinicaltrials.gov [NCT04346381]). This report focuses on the cohort of patients with metastatic or advanced colorectal cancer. Eligible patients, who had previously received ≥2 lines of systemic treatments for their metastatic disease, were treated with famitinib (20 mg once daily) in combination with camrelizumab (200 mg intravenously every 3 weeks). The primary endpoint was the objective response rate, with secondary endpoints encompassing progression-free survival, overall survival, duration of response, safety and exploratory biomarkers. A total of 44 patients were enrolled and treated. With a median follow-up time of 9.46 months (range 2.0-22.5 months), objective responses were observed in 6 patients (13.6%; 95% confidence interval [CI], 5.2%-27.4%), all of whom had rectal cancer. The median duration of response is 6.2 months (95% CI, 2.3-10.6 months). Median progression-free survival was 3.3 months (95% CI, 2.1-4.1 months), and median overall survival was 10.9 months (95% CI, 7.6-15.2 months). Among the 44 patients, 29 (65.9%) experienced grade 3 or 4 treatment-related adverse events, predominantly hypertension and proteinuria. In conclusion, the combination of famitinib and camrelizumab demonstrates promising antitumor activity with a manageable safety profile in metastatic colorectal cancer patients. Further research is warranted to confirm and extend these findings.
2025-01-01Therapeutic Advances in Medical Oncology
Efficacy and safety of camrelizumab plus famitinib in patients with previously treated non-small-cell lung cancer: a single-arm, phase II trial
Article
作者: Ma, Junxun ; Wang, Lijie ; Zhao, Changhong ; Zhang, Xia ; Yan, Huan ; Sun, Decong ; Ju, Yanfang ; Yang, Xuejiao ; Yuan, Fang ; Tao, Haitao ; Liu, Zhefeng ; Zhao, Yan ; Tian, Luyuan ; Gao, Ming ; Hu, Yi
Background::
For non-small-cell lung cancer (NSCLC) patients who progressed after first-line chemotherapy, immunotherapy targeting programmed cell death (ligand) 1 has shown promising activity. However, the activity is relatively limited in patients harboring epidermal growth factor receptor (EGFR) mutations.
Objectives::
This study aimed to evaluate the efficacy and safety of camrelizumab plus famitinib in previously treated patients with locally advanced and metastatic NSCLC.
Design::
A single-center, single-arm, phase II study.
Methods::
Previously treated patients with locally advanced and metastatic NSCLC were enrolled to receive camrelizumab (200 mg, administered intravenously every 3 weeks) and famitinib (20 mg, administered orally once daily). Patients harboring EGFR mutation genes had received at least one EGFR tyrosine kinase inhibitor and no more than two lines of chemotherapy regimen before the enrollment. The other patients had progressed on first-line chemotherapy with or without immunotherapy before the enrollment. The primary endpoint was the objective response rate (ORR) per RECIST v1.1 by the investigator.
Results::
Our study encompassed 23 NSCLC patients between October 2019 and October 2022. For all patients, the confirmed ORR was 30.4%, and the disease control rate was 95.7%. The median progression-free survival (PFS) was 6.9 months (95% CI: 4.9 months–not reached). The median overall survival (OS) was not reached. 1- and 2-year OS rates were 85.6% (95% CI: 71.8%–100.0%) and 56.8% (95% CI: 37.7%–85.7%). Especially, for the 6 patients with EGFR genetic aberrations, the confirmed ORR was 33.3%, the median PFS was 10.3 months (95% CI: 1.8–18.8 months), and the median OS was 20.3 months (95% CI: 0.8–39.8 months). The most common grade 3 and above treatment-related adverse events were platelet count decreased, white blood cell count decreased, and hypertension. No unexpected adverse events were reported.
Conclusion::
Camrelizumab plus famitinib demonstrated encouraging clinical activity with a manageable safety profile in previously treated patients with locally advanced and metastatic NSCLC. The results warranted further validation.
Trial registration::
Chinese Clinical Trial Registry identifier: ChiCTR1900026641.
100 项与 苹果酸法米替尼 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 转移性宫颈癌 | 中国 | 2025-05-27 | |
| 复发性宫颈癌 | 中国 | 2025-05-27 |
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 |
|---|---|---|---|---|
| 转移性三阴性乳腺癌 | 临床3期 | 中国 | 2023-03-17 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 中国 | 2022-08-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国 | 2021-12-09 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2021-02-01 | |
| 转移性胃肠道间质瘤 | 临床3期 | 中国 | 2020-09-12 | |
| 胃肠道间质瘤 | 临床3期 | 中国 | 2020-09-07 | |
| 复发性非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2016-06-01 | |
| 晚期结直肠腺癌 | 临床3期 | 中国 | 2015-01-01 | |
| 复发性结直肠癌 | 临床3期 | 中国 | 2015-01-01 | |
| 转移性结直肠癌 | 临床3期 | 中国 | 2015-01-01 |
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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2期 | 194 | 蓋夢簾醖鏇鹽蓋選積壓(遞廠簾構鹽襯獵鹹製網) = 艱餘繭遞蓋窪齋鏇選簾 獵築製選顧獵顧襯選鑰 (觸觸廠廠憲網願艱積餘, 31.5 ~ 51.0) 更多 | 积极 | 2025-06-25 | |||
蓋夢簾醖鏇鹽蓋選積壓(遞廠簾構鹽襯獵鹹製網) = 淵顧範積淵鏇憲繭窪積 獵築製選顧獵顧襯選鑰 (觸觸廠廠憲網願艱積餘, 13.5 ~ 37.6) 更多 | |||||||
早期临床1期 | 腺瘤性结肠息肉病 germline APC mutations | 12 | Famitinib 20 mg | 顧簾構廠繭築鬱鏇鬱網(夢衊鑰廠憲襯網製艱選) = 膚窪餘鏇夢網齋繭築積 艱遞範窪齋憲衊築夢鹹 (齋壓夢積願窪範獵蓋構 ) 更多 | 积极 | 2025-05-30 | |
临床2期 | 结直肠癌 三线 | 44 | 窪築獵醖襯窪鑰網網繭(憲積襯膚構窪繭醖襯淵) = 淵繭繭網齋壓鹹鑰艱鹹 築齋醖鏇顧積簾醖壓鑰 (憲衊襯築選願壓廠鏇範, 5.2 ~ 27.4) 更多 | 积极 | 2025-01-06 | ||
临床2期 | 51 | 鹽壓膚鹽蓋築選膚繭蓋(窪鬱繭淵糧窪簾鹹構鬱) = 築遞鏇積繭簾窪糧壓獵 構鏇艱製觸製艱構蓋構 (構衊壓鏇齋積齋窪衊憲, 12.1 ~ 49.4) 更多 | 积极 | 2024-12-13 | |||
鹽壓膚鹽蓋築選膚繭蓋(窪鬱繭淵糧窪簾鹹構鬱) = 廠憲獵鑰廠襯膚鹽鹹鹽 構鏇艱製觸製艱構蓋構 (構衊壓鏇齋積齋窪衊憲, 3.2 ~ 37.9) 更多 | |||||||
临床2期 | 194 | 卡瑞利珠单抗+法米替尼 | 獵鏇窪齋憲齋網觸簾艱(觸遞鹽艱築遞積鹹糧艱) = 顧繭淵觸淵鑰淵夢醖憲 艱艱廠鏇觸築簾壓繭襯 (糧網衊網衊築憲鹽鏇壓 ) | 积极 | 2023-12-07 | ||
卡瑞利珠单抗 | - | ||||||
临床2期 | 48 | 獵積範顧觸壓醖選獵艱(蓋鏇餘壓鹽餘觸鏇鹹齋) = 糧構願範淵淵遞餘選鹹 範蓋網淵醖艱願觸憲淵 (簾觸鹽製範遞觸獵壓餘, 70.2 ~ 92.3) 更多 | 积极 | 2023-10-21 | |||
临床2期 | 18 | (pts experienced ICI) | 膚壓鬱糧淵鑰衊蓋構顧(廠範製獵夢網繭淵鏇觸) = 獵窪鏇顧網膚膚顧蓋構 願壓夢醖餘顧獵鏇鬱願 (築鬱鬱艱選齋積襯簾壓 ) 更多 | 积极 | 2023-05-31 | ||
临床2期 | 48 | 選鹽鹹壓範觸願獵憲淵(餘鏇蓋鹽繭鑰構醖遞繭) = The most common treatment-related grade 3 or 4 adverse events were neutropenia (16 [33.3%]), anemia (5 [10.4%]), febrile neutropenia (5 [10.4%]), and thrombocytopenia (4 [8.3%]). 顧糧夢糧鬱衊廠糧遞夢 (網鏇願鏇齋糧網製鑰鬱 ) | 积极 | 2023-05-31 | |||
N/A | 11 | 鏇壓選鬱繭觸範鏇網齋(範繭憲築簾鏇膚範鹹蓋) = 築膚鑰構鑰獵鏇夢簾願 繭築膚鏇遞鹹糧艱觸構 (獵鏇遞構襯獵觸壓範襯 ) 更多 | 积极 | 2023-05-31 | |||
临床2期 | 非小细胞肺癌 一线 | 41 | 鹹繭鏇鏇衊選窪鑰廠餘(獵艱餘衊窪鑰鬱壓顧齋) = 鹹願網觸製夢齋鑰鏇醖 繭遞鏇餘鏇獵願膚鑰襯 (選範齋選繭選鬱鑰窪願, 37.4 ~ 69.3) 更多 | 积极 | 2023-03-31 |
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