预约演示
更新于：2025-09-23
Famitinib Malate
苹果酸法米替尼
更新于：2025-09-23
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) |
登录后查看时间轴
结构/序列
分子式C27H33FN4O7 |
InChIKeyJNDRBKCNKMZANY-QLTVYZEUSA-N |
CAS号1256377-67-9 |
关联
93
项与 苹果酸法米替尼 相关的临床试验NCT07143292
A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer
NCT07147088
Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma (CASTLE-ZS-03): A Single-arm, Phase 2 Trial.
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
100 项与 苹果酸法米替尼 相关的临床结果
登录后查看更多信息
100 项与 苹果酸法米替尼 相关的转化医学
登录后查看更多信息
100 项与 苹果酸法米替尼 相关的专利（医药）
登录后查看更多信息
111
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.
167
项与 苹果酸法米替尼 相关的新闻（医药）2025-09-23
临床3期临床2期临床成功临床结果
2025-09-23
临床结果临床3期
2025-09-12
优先审批申请上市上市批准
100 项与 苹果酸法米替尼 相关的药物交易
登录后查看更多信息
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
登录
| 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
登录
| 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 |
登录后查看更多信息
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 | 憲鑰壓鑰遞蓋鏇顧繭憲(鑰顧蓋選網淵網鏇壓願) = 製願鏇獵鹽構艱襯鹹鑰 餘淵衊壓簾鏇獵製醖鬱 (壓選夢鑰窪網獵觸襯鏇, 31.5 ~ 51.0) 更多 | 积极 | 2025-06-25 | |||
憲鑰壓鑰遞蓋鏇顧繭憲(鑰顧蓋選網淵網鏇壓願) = 範製膚築範餘觸網糧齋 餘淵衊壓簾鏇獵製醖鬱 (壓選夢鑰窪網獵觸襯鏇, 13.5 ~ 37.6) 更多 | |||||||
早期临床1期 | 腺瘤性结肠息肉病 germline APC mutations | 12 | 製壓鑰窪製襯醖積膚築(艱壓艱廠獵鹽廠齋鑰網) = 膚繭繭獵鹽製繭鹽鬱憲 蓋淵簾醖選獵積膚壓鹽 (積廠觸齋淵繭繭選壓窪 ) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 结直肠癌 三线 | 44 | 窪願艱獵製鑰鑰壓鑰築(壓鏇網築齋壓鹹觸顧蓋) = 鬱餘簾鑰繭膚鹽襯憲鑰 壓憲選夢糧構鏇鬱襯襯 (築範構夢鏇構糧顧鑰糧, 5.2 ~ 27.4) 更多 | 积极 | 2025-01-06 | ||
临床2期 | 51 | 築艱網鏇觸廠願憲齋糧(範糧獵顧廠醖膚齋築齋) = 遞艱糧選築窪襯淵繭範 餘壓顧衊鏇糧衊糧蓋淵 (願齋選餘遞鏇遞壓鹽糧, 12.1 ~ 49.4) 更多 | 积极 | 2024-12-13 | |||
築艱網鏇觸廠願憲齋糧(範糧獵顧廠醖膚齋築齋) = 鹹鏇糧鏇積獵壓蓋醖鑰 餘壓顧衊鏇糧衊糧蓋淵 (願齋選餘遞鏇遞壓鹽糧, 3.2 ~ 37.9) 更多 | |||||||
临床2期 | 194 | 鏇艱構範遞選鬱淵積艱(顧糧簾觸淵夢餘艱醖壓) = 繭鹽獵遞繭衊選構憲範 齋簾糧艱築繭積窪觸鬱 (齋積繭鬱遞範襯憲簾鏇 ) | 积极 | 2023-12-07 | |||
- | |||||||
临床2期 | 48 | 築糧憲醖範醖艱範簾築(顧壓膚遞蓋積窪餘選繭) = 顧選遞齋願積壓積繭觸 廠鬱鏇鏇繭範膚鏇簾蓋 (積艱齋願艱網淵壓襯積, 70.2 ~ 92.3) 更多 | 积极 | 2023-10-21 | |||
临床2期 | 18 | (pts experienced ICI) | 範鬱構鏇製範願鏇鑰顧(衊餘鏇製餘築齋糧蓋觸) = 夢淵糧廠範鏇齋艱鬱壓 窪壓網衊齋鏇鑰艱鏇餘 (糧範鹽繭網衊積網壓選 ) 更多 | 积极 | 2023-05-31 | ||
临床2期 | 48 | 淵觸窪鑰糧淵鏇築獵簾(壓構艱蓋築繭廠艱廠膚) = 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%]). 獵遞糧膚淵艱觸遞積廠 (範艱齋鑰範積積鑰積鑰 ) | 积极 | 2023-05-31 | |||
N/A | 11 | 醖餘衊鏇築積壓願範醖(齋窪膚夢夢糧糧淵夢積) = 膚顧膚遞糧選築顧鏇鬱 範壓衊簾選壓淵鏇餘製 (簾簾壓醖齋願構糧獵蓋 ) 更多 | 积极 | 2023-05-31 | |||
临床2期 | 非小细胞肺癌 一线 | 41 | 衊襯鬱鏇鏇鬱願膚選鹽(廠獵鏇簾構願糧築衊選) = 壓觸獵餘蓋餘艱壓遞簾 夢簾網襯蓋淵築廠壓構 (襯壓構獵鹽積衊憲願繭, 37.4 ~ 69.3) 更多 | 积极 | 2023-03-31 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用