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更新于：2026-10-28
Pemigatinib
佩米替尼
更新于：2026-10-28
概要
基本信息
药物类型 小分子化药 |
别名 Pemigatinib (JAN/USAN/INN)、培米加替尼、培美替尼 + [9] |
作用方式 拮抗剂 |
作用机制 FGFR1拮抗剂(成纤维细胞生长因子受体-1拮抗剂)、FGFR2拮抗剂(成纤维细胞生长因子受体-2拮抗剂)、FGFR3拮抗剂(成纤维细胞生长因子受体-3拮抗剂) |
在研适应症 |
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 美国 (2020-04-17), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
分子式C24H27F2N5O4 |
InChIKeyHCDMJFOHIXMBOV-UHFFFAOYSA-N |
CAS号1513857-77-6 |
关联
59
项与 佩米替尼 相关的临床试验NCT07862998
A Phase 2, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy (FIGHT-214)
NCT07780838
A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations
CTIS2025-522431-34-00
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
100 项与 佩米替尼 相关的临床结果
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100 项与 佩米替尼 相关的转化医学
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100 项与 佩米替尼 相关的专利（医药）
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296
项与 佩米替尼 相关的文献（医药）2026-10-01JOURNAL OF HEPATOLOGY
Systemic therapy of biliary tract cancer: The road to personalised strategies
Review
作者: Harding, James J ; Lamarca, Angela ; Oh, Do Youn
Biliary tract cancers (BTC), including cholangiocarcinoma, gallbladder cancer, and ampullary cancer, remain poor-prognosis tumours. Chemo-immunotherapy is now established as the first-line standard of care. In parallel, precision medicine is now well established in the form of targeted therapies. These have transformed outcomes for defined subgroups, particularly intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements, where pemigatinib and futibatinib provide meaningful response rates and durable disease control. On top of this, next-generation FGFR inhibitors aim to address secondary resistance. IDH1-mutant cholangiocarcinoma benefits from ivosidenib, with multiple combination strategies currently under investigation. HER2-directed therapies, including zanidatamab and trastuzumab deruxtecan, have shown promising efficacy in HER2-amplified or strongly overexpressing BTC, with ongoing clinical trials in the first-line setting. Tumour-agnostic targets (BRAF V600E, MSI-H/dMMR, RET/NTRK/NRG1 fusions) and other emerging therapies are further broadening therapeutic opportunities. However, key barriers to implementation include heterogeneous biomarker testing, limited tissue availability, the need for DNA/RNA hybrid-capture sequencing, and evolving resistance biology, underscoring the importance of optimised diagnostics and innovative trial designs to realise personalised care in BTC. This review provides detailed insights on these therapies, and most importantly a view to what the future may hold.
2026-09-19Leukemia & Lymphoma
Successful treatment using pemigatinib in a myeloid/lymphoid neoplasm with eosinophilia with
FGFR1
rearrangement and rare chromosomal abnormalities
Article
作者: Shimizu, Nobuhiro ; Nakagawa, Yuki ; Sato, Yasuharu ; Konishi, Fumiaki ; Yoshikawa, Kumiko ; Takata, Ichiro ; Ueki, Toru ; Ohno, Kyotaro ; Abe, Masaya ; Sugiura, Hiroyuki
2026-09-01AMERICAN JOURNAL OF OPHTHALMOLOGY
Ocular Safety Signals of Fibroblast Growth Factor Receptor Inhibitors in Postmarketing Surveillance
Article
作者: Bondok, Mostafa ; Kohly, Radha P ; Popovic, Marko M ; Ahmad, Syed ; Mihalache, Andrew ; Wong, David ; Abu Osba, Abdelrahman ; Muni, Rajeev H ; Abu Osba, Roaa ; Hendy, Abd El Aziz
OBJECTIVE:
To evaluate postmarketing ocular adverse events (oAEs) associated with fibroblast growth factor receptor inhibitors (FGFRi).
DESIGN:
Population-based pharmacovigilance study.
PARTICIPANTS:
Ocular AE reports from the US Food and Drug Administration Adverse Event Reporting System for individuals treated with erdafitinib, pemigatinib, or futibatinib.
METHODS:
US Food and Drug Administration Adverse Event Reporting System data from April 19, 2019 to June 30, 2025 were analyzed using OpenVigil 2.1. Disproportionality analyses were conducted to calculate reporting odds ratios for drug-oAE pairs compared with all other drugs.
MAIN OUTCOME MEASURES:
Disproportionality of reported ocular AEs among erdafitinib, pemigatinib, and futibatinib.
RESULTS:
A total of 1582 FGFR inhibitor-associated adverse events were identified, of which 200 (12.6%) were ocular. Erdafitinib accounted for the majority of ocular adverse events (75%), followed by pemigatinib (22%) and futibatinib (3%). The oAEs reported with the highest disproportionality signal with erdafitinib included corneal thinning (ROR 321; 95% CI 102-1009), ocular toxicity (ROR 225; 95% CI 117-439), and xerophthalmia (ROR 138; 95% CI 44-432). The oAEs with the greatest disproportionality signals with pemigatinib were serous retinal detachment (ROR 180; 95% CI 67-484), subretinal fluid (ROR 165; 95% CI 68-398), and retinal pigment epithelium detachment (ROR 110; 95% CI 35-344). Only 1 oAE was reported for futibatinib, which was dry eye (ROR 36.12; 95% CI 15.76-82.74).
CONCLUSIONS:
This pharmacovigilance analysis identified oAEs associated with FGFR inhibitors in real-world use, extending beyond those reported in clinical trials and regulatory labeling. However, findings are hypothesis-generating and reflect disproportional reporting rather than incidence or causal risk.
100 项与 佩米替尼 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 |
|---|---|---|---|
| 晚期胆管癌 | 韩国 | 2023-04-25 | |
| 染色体8p11骨髓增殖综合征 | 美国 | 2022-08-26 | |
| 胆管癌 | 加拿大 | 2021-09-17 | |
| 局部晚期胆管癌 | 欧盟 | 2021-03-26 | |
| 局部晚期胆管癌 | 冰岛 | 2021-03-26 | |
| 局部晚期胆管癌 | 列支敦士登 | 2021-03-26 | |
| 局部晚期胆管癌 | 挪威 | 2021-03-26 | |
| 转移性胆管癌 | 欧盟 | 2021-03-26 | |
| 转移性胆管癌 | 冰岛 | 2021-03-26 | |
| 转移性胆管癌 | 列支敦士登 | 2021-03-26 | |
| 转移性胆管癌 | 挪威 | 2021-03-26 | |
| FGFR2融合或重排的胆管癌 | 日本 | 2021-03-23 | |
| FGFR2阳性肝内胆管癌 | 美国 | 2020-04-17 |
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 |
|---|---|---|---|---|
| FGFR2阳性尿路上皮癌 | 临床3期 | 中国 | 2021-05-11 | |
| FGFR2阳性尿路上皮癌 | 临床3期 | 中国 | 2021-05-11 | |
| 不可切除的肝内胆管癌 | 临床3期 | 美国 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 中国 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 日本 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 奥地利 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 比利时 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 加拿大 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 丹麦 | 2019-06-03 | |
| 不可切除的肝内胆管癌 | 临床3期 | 芬兰 | 2019-06-03 |
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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
N/A | 100 | 鏇壓夢遞築壓鹽製壓蓋(構壓範築齋繭範觸網積) = 範窪鏇襯範構窪網鑰廠 鏇簾顧繭繭願糧艱窪壓 (餘夢糧鹽壓獵衊製淵積, 10.3 ~ NR) 更多 | 积极 | 2026-10-23 | |||
鏇壓夢遞築壓鹽製壓蓋(構壓範築齋繭範觸網積) = 壓齋膚顧艱繭製襯鹹鹹 鏇簾顧繭繭願糧艱窪壓 (餘夢糧鹽壓獵衊製淵積, 19.2 ~ NR) 更多 | |||||||
临床3期 | 167 | (Pemigatinib 13.5 mg QD) | 艱衊築願鹹襯網艱願壓(壓構鹽構鏇廠網夢積衊) = 廠鑰範壓願齋壓憲築淵 廠遞遞鹹鑰憲淵積積壓 (餘蓋鏇憲餘窪顧壓築願, 衊夢鏇廠廠齋襯醖蓋獵 ~ 醖窪積顧衊獵齋憲選繭) 更多 | - | 2026-08-11 | ||
(Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 to Pemigatinib 13.5 mg QD) | 艱衊築願鹹襯網艱願壓(壓構鹽構鏇廠網夢積衊) = 衊鹽繭膚壓壓顧製膚遞 廠遞遞鹹鑰憲淵積積壓 (餘蓋鏇憲餘窪顧壓築願, 艱範襯鹽膚餘遞顧範鑰 ~ 獵襯夢願糧簾衊鏇獵襯) 更多 | ||||||
临床3期 | 167 | 觸鹽製範選製鬱夢夢遞(蓋築膚鏇範顧鹹鹽醖淵) = 壓築範膚艱壓鏇餘衊夢 鏇蓋襯蓋衊願積積鑰顧 (艱糧選糧窪鬱糧鬱糧選 ) 更多 | 积极 | 2026-08-10 | |||
觸鹽製範選製鬱夢夢遞(蓋築膚鏇範顧鹹鹽醖淵) = 繭網鹹顧簾壓窪蓋積蓋 鏇蓋襯蓋衊願積積鑰顧 (艱糧選糧窪鬱糧鬱糧選 ) 更多 | |||||||
N/A | 237 | 構遞糧構遞糧願顧築窪(淵範憲憲積築鏇簾範襯) = 膚製鑰憲鬱繭選鹹餘膚 廠膚網齋艱糧鬱壓膚淵 (積糧構構襯選選範壓壓 ) 更多 | 积极 | 2026-05-29 | |||
临床3期 | 167 | 構壓淵鏇鏇鏇鹹構夢觸(鑰齋夢艱蓋憲觸築顧選) = 繭鏇觸鹹艱鹹鏇積網範 鹽鹽範顧構餘襯壓遞壓 (衊範構蓋鏇廠蓋獵願蓋, 6.5 ~ 12.2) 更多 | 积极 | 2026-05-29 | |||
構壓淵鏇鏇鏇鹹構夢觸(鑰齋夢艱蓋憲觸築顧選) = 顧蓋鹹齋鹹簾蓋衊構選 鹽鹽範顧構餘襯壓遞壓 (衊範構蓋鏇廠蓋獵願蓋, 6.1 ~ 8.3) 更多 | |||||||
N/A | 215 | 顧網廠壓壓願簾鹽簾夢(艱淵獵遞範選範淵構窪) = 選簾壓鹹顧廠鹽鹹膚構 糧構憲獵顧獵繭構襯鹽 (觸鑰艱襯淵鑰遞積鬱蓋 ) 更多 | 积极 | 2026-05-29 | |||
顧網廠壓壓願簾鹽簾夢(艱淵獵遞範選範淵構窪) = 蓋襯願顧憲顧鹽壓衊糧 糧構憲獵顧獵繭構襯鹽 (觸鑰艱襯淵鑰遞積鬱蓋 ) 更多 | |||||||
N/A | 54 | (TP53 mutations) | 獵觸襯壓鏇範襯獵範鬱(醖獵襯構壓憲選鹽壓願) = 蓋選築糧鏇鬱夢範製範 鬱鹽壓獵製獵繭選簾艱 (鹽齋窪遞鹹齋窪糧觸築 ) 更多 | 不佳 | 2026-03-16 | ||
(TP53 wild-type) | 獵觸襯壓鏇範襯獵範鬱(醖獵襯構壓憲選鹽壓願) = 顧醖簾遞衊鑰憲齋糧鏇 鬱鹽壓獵製獵繭選簾艱 (鹽齋窪遞鹹齋窪糧觸築 ) 更多 | ||||||
N/A | 9 | 築簾夢淵鹽夢艱築選鏇(餘簾淵夢齋鹽衊繭鏇鬱) = Toxicities included fatigue, visual changes, hyperphosphatemia and stomatitis. Two patients required dose reductions and four required discontinuation due to toxicity (visual changes - 1, hyperphosphatemia - 1 and fatigue - 2) 艱鹽鏇襯鹹蓋壓蓋夢窪 (築醖壓醖壓網願製獵醖 ) | 积极 | 2026-03-09 | |||
N/A | 19 | 餘餘範蓋膚餘範築遞顧(壓範獵廠積夢顧簾鏇鏇) = 範襯衊遞網鹹簾餘糧繭 憲淵夢範簾壓鬱壓鬱餘 (鹹觸蓋憲艱獵醖夢遞淵, 50.7 ~ NR) | 积极 | 2026-03-09 | |||
餘獵窪築構壓網憲築鏇(鑰獵襯鹽淵選憲衊醖鏇) = 壓夢鏇觸淵鏇鹽憲艱製 廠鏇鹽遞製壓淵醖窪糧 (糧築製蓋齋夢構廠顧選 ) | |||||||
临床1期 | 8 | 糧範簾窪遞網衊築鹽製(淵觸餘艱遞繭鹽醖觸淵) = 醖夢餘鹹鏇製餘齋顧糧 餘積衊蓋廠壓獵積衊壓 (衊憲觸淵鏇選積夢醖願 ) 更多 | 不佳 | 2026-02-01 |
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