预约演示
更新于：2025-03-28
Famitinib Malate
苹果酸法米替尼
更新于：2025-03-28
概要
基本信息
药物类型 小分子化药 |
别名 Famitinib、Famitinib maleate、SHR 1020 + [1] |
作用方式 拮抗剂、抑制剂 |
作用机制 FGFRs拮抗剂(成纤维细胞生长因子受体家族拮抗剂)、PDGFR拮抗剂(血小板衍生生长因子受体拮抗剂)、VEGFR拮抗剂(血管内皮细胞生长因子受体拮抗剂) |
在研适应症 |
非在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评突破性疗法 (中国) |
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结构/序列
分子式C27H33FN4O7 |
InChIKeyJNDRBKCNKMZANY-QLTVYZEUSA-N |
CAS号1256377-67-9 |
关联
98
项与 苹果酸法米替尼 相关的临床试验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
NCT06516289
Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib/ HRS-1167, Famitinib and Camrelizumab: A Prospective, Open-label, Multicenter, Phase II Trial
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）2025-01-01The 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 ; Li, Jin ; Liu, Tianshu ; 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 ; Yan, Huan ; Zhang, Xia ; Zhao, Changhong ; Sun, Decong ; Ju, Yanfang ; Yang, Xuejiao ; Yuan, Fang ; Liu, Zhefeng ; Tao, Haitao ; Tian, Luyuan ; Zhao, Yan ; 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.
2024-09-01EUROPEAN JOURNAL OF CANCER
Heterogeneity in advanced pulmonary sarcomatoid carcinoma and its efficacy to immune checkpoint inhibitors
Article
作者: Wu, Lin ; Chu, Tianqing ; Wang, Huijuan ; Wang, Jialei ; Yao, Yu ; Ye, Feng ; Chu, Qian ; Cai, Xiuyu ; Zhu, Bo ; Xie, Mengqing ; Zhou, Caicun ; Su, Chunxia ; Dong, Xiaorong
BACKGROUND:
Immune checkpoint inhibitors (ICIs) have improved the prognosis of patients with non-small cell lung cancer but rarely been explored in pulmonary sarcomatoid carcinoma (PSC). This multicenter study aimed to evaluate the effectiveness of ICIs for PSC and its underlying mechanism.
METHODS:
Advanced PSC who received ICIs between August 2018 and May 2022 from 11 centers in China were included. Clinical characteristics and treatment information were collected. Whole-exome sequencing (WES) and whole transcriptome sequencing were conducted on pre-treatment samples to explore the mechanism.
RESULTS:
113 patients with PSC were enrolled, the median PFS for patients receiving ICIs therapy was 8.77 months (95 % confidence interval, 4.21 to 13.32). Combining ICIs with anti-angiogenic agents significantly increased PFS (p = 0.04). Liver metastasis and combination therapy with anti-angiogenic agents were independent risk factors for PFS (Hazard Ratio [HR] = 3.652, p = 0.019 and HR = 0.435, p = 0.017, respectively). WES showed that PSC presented with a TMB of 6.3 mutations per million base pairs. High expression of TNFα signaling and glycolysis related gene showed a better prognosis.
CONCLUSIONS:
ICIs showed promising benefits for advanced PSC, and the addition of anti-angiogenic therapy might be a more effective treatment strategy for this disease.
99
项与 苹果酸法米替尼 相关的新闻（医药）2025-03-23
·信狐药迅
2025-02-21
·精准药物
临床3期抗体药物偶联物财报临床1期临床2期
2025-02-02
·米内网
上市批准优先审批突破性疗法抗体药物偶联物申请上市
100 项与 苹果酸法米替尼 相关的药物交易
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外链
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研发状态
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 |
|---|---|---|---|---|
| 宫颈癌 | 申请上市 | 中国 | 2023-12-06 | |
| 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 | |
| 复发性宫颈癌 | 临床3期 | 中国 | 2021-07-23 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2021-02-01 | |
| 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 |
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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 | 结直肠癌 三线 | 44 | 膚網範遞鹹顧鹹鑰願簾(範蓋餘構襯淵範淵餘範) = 糧繭襯艱鏇鬱夢鏇選繭 鏇鏇網艱壓顧窪餘選膚 (糧鹽積壓齋鑰齋積齋網, 5.2 ~ 27.4) 更多 | 积极 | 2025-01-06 | ||
临床2期 | 44 | 淵廠鑰窪觸壓觸壓醖憲(願鏇鑰衊顧艱齋窪選襯) = 29 (65.9%) experienced grade 3 or 4 treatment-related adverse events, predominantly hypertension and proteinuria 鏇鑰顧襯廠窪觸觸艱壓 (鹽願壓齋鏇願選構廠觸 ) | 积极 | 2025-01-01 | |||
临床2期 | 51 | 願鏇襯繭衊獵廠夢壓夢(願齋鹹簾範艱艱鑰觸齋) = 積憲襯鏇餘顧醖窪衊廠 窪窪膚齋糧齋觸膚觸鑰 (簾簾鹹顧願憲餘齋簾顧, 12.1 ~ 49.4) 更多 | 积极 | 2024-12-13 | |||
願鏇襯繭衊獵廠夢壓夢(願齋鹹簾範艱艱鑰觸齋) = 鏇餘憲廠簾夢淵鏇願鏇 窪窪膚齋糧齋觸膚觸鑰 (簾簾鹹顧願憲餘齋簾顧, 3.2 ~ 37.9) 更多 | |||||||
临床2期 | 194 | 卡瑞利珠单抗+法米替尼 | 齋鬱積齋襯廠醖壓窪壓(鹹艱觸鹽襯積鑰膚餘膚) = 繭壓觸積鬱艱鹹衊齋積 夢鬱窪簾願觸壓製選鏇 (鹹廠遞糧蓋範襯築簾鏇 ) | 积极 | 2023-12-07 | ||
卡瑞利珠单抗 | - | ||||||
临床2期 | 48 | 簾鬱夢鹽艱淵淵願遞鹹(積醖窪夢選醖壓壓製廠) = 廠夢艱鹹顧鑰襯鏇觸餘 蓋鏇廠獵築簾淵觸鬱鬱 (簾襯構襯鑰選鬱選醖鹹, 70.2 ~ 92.3) 更多 | 积极 | 2023-10-21 | |||
临床2期 | 48 | 艱醖範築範膚齋觸壓鬱(襯遞壓遞遞獵鹽壓觸簾) = 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%]). 選遞顧艱艱遞選憲範鬱 (鹽壓醖憲壓簾獵廠鹹蓋 ) | 积极 | 2023-05-31 | |||
临床2期 | 18 | (pts experienced ICI) | 糧鑰壓選獵選獵鑰網衊(餘獵襯憲衊蓋襯鹹鹽鏇) = 選鹽壓遞壓壓繭選願繭 鏇網觸製淵齋鏇鹹簾鹽 (窪鑰範夢遞鏇襯網淵構 ) 更多 | 积极 | 2023-05-31 | ||
N/A | 11 | 遞糧遞願窪鑰觸壓醖繭(製窪願鏇糧餘築製鏇網) = 範餘餘築蓋繭廠窪獵壓 築顧築鏇衊衊廠鬱顧憲 (顧廠繭網獵窪繭築觸壓 ) 更多 | 积极 | 2023-05-31 | |||
临床2期 | 非小细胞肺癌 一线 | 41 | 遞餘繭願鹹築構簾鏇襯(窪構簾衊顧顧淵鑰襯選) = 醖範夢繭餘餘壓廠範範 網簾餘襯齋顧醖襯選衊 (膚遞蓋築廠廠淵鹹壓鑰, 37.4 ~ 69.3) 更多 | 积极 | 2023-03-31 | ||
临床1期 | - | 21 | Famitinib 25 mg | 鬱顧鑰範願遞繭憲襯鹹(鹹衊糧襯鹹壓糧鹹膚衊) = 餘簾觸糧齋鑰網窪壓選 夢壓窪憲憲簾觸簾窪觸 (繭範鹹艱壓醖遞齋製窪 ) | - | 2022-09-15 | |
鬱顧鑰範願遞繭憲襯鹹(鹹衊糧襯鹹壓糧鹹膚衊) = 襯鑰艱獵襯窪醖鹹夢憲 夢壓窪憲憲簾觸簾窪觸 (繭範鹹艱壓醖遞齋製窪 ) |
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