预约演示
更新于：2026-09-02
Encorafenib
恩考芬尼
更新于：2026-09-02
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2018-06-27), |
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 (日本)、孤儿药 (韩国)、优先审评 (澳大利亚)、优先审评 (中国) |
登录后查看时间轴
结构/序列
分子式C22H27ClFN7O4S |
InChIKeyCMJCXYNUCSMDBY-ZDUSSCGKSA-N |
CAS号1269440-17-6 |
关联
109
项与 恩考芬尼 相关的临床试验DRKS00040588
Encorafenib in Combination with Binimetinib in Patients with BRAFV600E-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC): A Retrospective, Multi-Centre Case Series in Germany - AIRCASE
CTR20261861
评估受试制剂恩考芬尼胶囊与参比制剂恩考芬尼胶囊（Braftovi®）作用于健康成年男性试验参与者的单中心、开放、随机、单剂量、交叉餐后生物等效性研究
NCT07318389
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
100 项与 恩考芬尼 相关的临床结果
登录后查看更多信息
100 项与 恩考芬尼 相关的转化医学
登录后查看更多信息
100 项与 恩考芬尼 相关的专利（医药）
登录后查看更多信息
632
项与 恩考芬尼 相关的文献（医药）2026-12-31CNS oncology
Tailored management of a melanoma patient with bleeding brain metastases and deep vein thrombosis with thrombectomy
Article
作者: Ceccarelli, Corrado ; Pastina, Ilaria ; Del Roscio, Davide ; De Angelis, Filippo ; Viterbo, Antonella ; Pieraccini, Massimo ; Arezzini, Luca
CASE PRESENTATION:
We describe a 62-year-old man with disseminated melanoma (initially staged pT2aN0M0, AJCC stage IB, 8th edition AJCC) who developed multiple brain metastases with hemorrhagic transformation, pulmonary embolism, retrobulbar progression with eyeball herniation, and deep vein thrombosis (DVT). After cerebral edema improved with corticosteroid tapering and the patient became asymptomatic, he started combination immunotherapy with ipilimumab (3 mg/kg q3w × 4) and nivolumab (1 mg/kg q3w × 4). Despite initial benefit, progression led to radiotherapy for retrobulbar lesion and subsequent targeted therapy with encorafenib (450 mg daily) and binimetinib (45 mg twice daily). Shortly after, the patient developed symptomatic left-leg DVT extending to the femoral vein with segmental pulmonary embolism. Given the contraindication to full anticoagulation, mechanical thrombectomy with the Indigo Aspiration System was performed, followed by prophylactic LMWH at reduced therapeutic dose (enoxaparin 1 mg/kg once daily due to recent thrombectomy and hemorrhagic risk from bleeding brain metastases). During targeted therapy, the patient experienced partial regression of brain, liver, and peritoneal metastases, although intracranial hemorrhage recurred later.
CONCLUSIONS:
This case highlights the value of a multidisciplinary, tailored approach integrating immunotherapy, radiotherapy, targeted therapy, and mechanical thrombectomy with no DVT recurrence observed following thrombectomy at 6-month follow-up.
2026-12-01MOLECULAR BIOLOGY REPORTS
Recent progress in clinical and molecular biological research in rectal serrated lesions
Review
作者: Xu, Yuan ; Zeng, Xiaoyan ; Liu, Ling
Colorectal cancer ranks among the most common malignancies worldwide. Rectal serrated lesions represent a significant precancerous condition, accounting for approximately 30% of sporadic colorectal carcinomas. Their flat morphology and indistinct borders often lead to missed detection during routine colonoscopy. In addition, the complex classification system and considerable molecular heterogeneity of these lesions create challenges for clinical management, including diagnostic accuracy, risk stratification, and treatment decisions. Research in recent years has progressively clarified the unique oncogenic pathway associated with serrated lesions-referred to as the serrated pathway. Characteristic molecular events include mutations in b-raf murine sarcoma viral oncogene homolog B (BRAF) or kirsten rat sarcoma viral proto-oncogene (KRAS) mutations, CpG island methylator phenotype (CIMP), and microsatellite instability (MSI). Among these, the BRAF V600E mutation serves as the core driver event. Combination therapy with encorafenib and cetuximab, which targets this mutation, has been shown to improve outcomes in patients with BRAF-mutated metastatic colorectal cancer. Furthermore, Microsatellite Instability-High (MSI-H) lesions exhibit sensitivity to immune checkpoint inhibitors, offering novel options for personalized treatment. Concurrently, the application of technologies such as artificial intelligence (AI)-assisted endoscopy, molecular imaging, and liquid biopsy holds promise for improving the detection of early-stage lesions. This systematic review examines the current research landscape regarding rectal serrated lesions, covering an evolution of classification systems, elucidation of molecular and cellular mechanism, advances in diagnostic technology, and optimized treatment strategies. We further discussed molecular differences between the serrated pathway and the classical adenoma-carcinoma sequence, epigenetic regulatory mechanisms, tumour microenvironment characteristics, and personalized management strategies based on molecular subtyping. By synthesizing existing evidence, this review aims to provide theoretical guidance for the clinical management of rectal serrated lesions and lay the groundwork for future research.
2026-09-01EUROPEAN JOURNAL OF CANCER
primary analysis of the RANDOMIZED eortc-2139/columbus-ad trial: Adjuvant encorafenib and binimetinib versus placebo in high-risk stage II BRAF-V600E/K melanoma
Article
作者: Pagès-Laurent, Pages-LaurentCecile ; Pracht, Marc ; Long, Georgina V ; Jouary, Thomas ; Machet, Laurent ; Klauck, Isabelle ; Tomczak, Piotr ; Krajsova, Ivana ; Lorigan, Paul C ; Del Vecchio, Michele ; Sansas, Benoît ; Rutkowski, Piotr ; Nuyens, Sarah ; van Akkooi, Alexander Cj ; Berciano, Miguel Ga ; de Schaetzen, Gaetan ; Palmieri, Giuseppe ; Mortier, Laurent ; De Galitiis, Federica ; Jha, Nitish ; Quereux, Gaëlle ; Mandala, Mario ; Massi, Daniela ; Dutriaux, Caroline ; Eggermont, Alexander Mm ; Merelli, Barbara ; Arenberger, Petr ; Matkovic, Suzana ; Ascierto, Paolo A ; Kapiteijn, Ellen ; Hauschild, Axel ; Jalving, Mathilde ; Vantuchova, Yvetta ; Govaerts, Anne-Sophie ; Kicinski, Michal ; Elaut, Nathalie ; Gebhardt, Christoffer ; Vedovato, Jean Claude
PURPOSE:
Stage IIB/IIC melanoma has a high risk of recurrence after resection. Combined BRAF/MEK inhibitor therapy showed benefit in resected high-risk stage III and advanced melanoma. The objective of this study was to investigate its role in stage IIB/IIC.
METHODS:
Adult patients with resected stage IIB/IIC cutaneous melanoma which had a BRAF V600E/K mutation were randomized 1:1 to receive encorafenib (enco) 450 mg QD + binimetinib (bini) 45 mg BID orally for one year or placebo. The study planned to randomize 815 patients and was designed to demonstrate superiority regarding recurrence-free survival (RFS). Following a premature termination of accrual, the study was amended with safety as the primary endpoint and RFS as secondary endpoint.
RESULTS:
Between June 9, 2022, and October 9, 2023, 339 patients were screened for a BRAF mutation and 110 randomized. Data cutoff was 19 Nov. 2024, after the last patient discontinued study participation. Among randomized patients, 87 (79%) had a BRAF V600E mutation, and 39 (35%) AJCC8 stage IIC. Median follow-up was 12 and 7 months for enco/bini and placebo arms, respectively. Among 54 patients who initiated enco + bini, grade ≥ 3 treatment-related adverse events (AE) occurred in 13 (24%) patients, and 18 (33%) patients had an AE leading to permanent treatment discontinuation. RFS at 12 months was 86% (95% CI: 65-95%) in the enco + bini and 70% (95% CI: 46-85%) in the placebo arm, distant metastasis-free survival at 12 months was 92% (95% CI: 77-97%) for enco + bini and 82% (95% CI: 55-93%) for placebo.
CONCLUSION:
EORTC 2139 - Columbus-AD demonstrated a consistent and manageable safety profile and encouraging efficacy results for the combination of enco and bini in resected stage IIB/C BRAF V600E/K-mutated cutaneous melanomas.
100 项与 恩考芬尼 相关的药物交易
登录后查看更多信息
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 |
|---|---|---|---|
| 结直肠癌 | 美国 | 2026-02-24 | |
| 黑色素瘤 | 美国 | 2026-02-24 | |
| 转移性结直肠癌 | 美国 | 2026-02-24 | |
| 不可切除的黑色素瘤 | 美国 | 2026-02-24 | |
| 转移性非小细胞肺癌 | 澳大利亚 | 2025-11-28 | |
| BRAF突变的甲状腺未分化癌 | 日本 | 2024-05-17 | |
| BRAF突变甲状腺癌 | 日本 | 2024-05-17 | |
| BRAF V600E突变非小细胞肺癌 | 美国 | 2023-10-11 | |
| BRAF突变阳性黑色素瘤 | 日本 | 2020-11-27 | |
| BRAF 突变结直肠癌 | 日本 | 2019-01-08 | |
| BRAF V600 突变阳性黑色素瘤 | 欧盟 | 2018-09-19 | |
| BRAF V600 突变阳性黑色素瘤 | 冰岛 | 2018-09-19 | |
| BRAF V600 突变阳性黑色素瘤 | 列支敦士登 | 2018-09-19 | |
| BRAF V600 突变阳性黑色素瘤 | 挪威 | 2018-09-19 | |
| BRAF V600E突变结直肠癌 | 欧盟 | 2018-09-19 | |
| BRAF V600E突变结直肠癌 | 冰岛 | 2018-09-19 | |
| BRAF V600E突变结直肠癌 | 列支敦士登 | 2018-09-19 | |
| BRAF V600E突变结直肠癌 | 挪威 | 2018-09-19 | |
| BRAF V600E阳性黑色素瘤 | 美国 | 2018-06-27 | |
| BRAF V600K 阳性黑色素瘤 | 美国 | 2018-06-27 |
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 |
|---|---|---|---|---|
| 皮肤黑色素瘤 | 临床3期 | 阿根廷 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 澳大利亚 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 奥地利 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 比利时 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 巴西 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 加拿大 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 捷克 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 法国 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 德国 | 2022-05-02 | |
| 皮肤黑色素瘤 | 临床3期 | 希腊 | 2022-05-02 |
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3期 | 841 | (SLI: Cohort 1 [EC + FOLFIRI]) | 鏇窪簾鑰顧鑰壓鏇艱獵 = 壓鬱窪鹹選製壓艱鹹艱 構醖醖網鑰窪築壓衊顧 (積鹽顧醖鹽醖窪製憲觸, 鬱鏇蓋窪鏇網廠觸糧顧 ~ 顧網餘膚顧繭糧獵廠壓) 更多 | - | 2026-06-11 | ||
(SLI: Cohort 2 [EC + mFOLFOX6]) | 鏇窪簾鑰顧鑰壓鏇艱獵 = 鹽積糧鏇顧膚構繭鹹艱 構醖醖網鑰窪築壓衊顧 (積鹽顧醖鹽醖窪製憲觸, 窪鹹構製鹹鑰艱齋糧膚 ~ 網繭願選範鏇製範鏇淵) 更多 | ||||||
临床2期 | 6 | 廠鑰範鬱構淵範鹽顧艱(遞遞選糧獵願願齋膚淵) = 糧蓋鹹鬱壓繭網壓觸膚 窪鏇鹽襯鑰襯憲鏇膚壓 (鏇積廠選夢夢獵淵糧網 ) 更多 | 积极 | 2026-05-29 | |||
临床2期 | BRAF V600E阳性黑色素瘤 BRAF V600E | 10 | 醖鑰齋鏇窪淵鏇淵願壓(網廠獵鹹構餘醖廠夢築) = only 6 grade 3 AEs in Arm B, 16 treatment-related grade 3 adverse events in Arm A 糧憲壓襯夢鹹範鬱顧選 (窪鹹壓廠鬱蓋鹹構鹹網 ) | 积极 | 2026-05-29 | ||
临床2期 | BRAF V600E突变结直肠癌 BRAF V600E | MSS | 85 | 艱顧憲構廠淵願獵鹽壓(餘製顧壓繭築築襯鬱簾) = 淵簾鏇衊廠觸製鬱壓齋 網艱窪製築觸憲網廠醖 (鏇網餘遞糧壓製觸鑰淵, 4.0 ~ 7.8) 更多 | 不佳 | 2026-05-29 | ||
艱顧憲構廠淵願獵鹽壓(餘製顧壓繭築築襯鬱簾) = 願襯衊壓壓衊醖顧顧廠 網艱窪製築觸憲網廠醖 (鏇網餘遞糧壓製觸鑰淵, 5.0 ~ 11.4) 更多 | |||||||
N/A | 162 | 願艱構壓窪遞觸夢夢齋(壓蓋鏇夢壓壓憲積鑰憲) = 獵鹽蓋鹹遞選鏇簾餘繭 壓構窪鹹衊鬱衊鏇鑰鏇 (製艱壓範製構構鏇鑰蓋 ) 更多 | 积极 | 2026-05-29 | |||
願艱構壓窪遞觸夢夢齋(壓蓋鏇夢壓壓憲積鑰憲) = 窪繭憲顧衊衊簾鹽糧齋 壓構窪鹹衊鬱衊鏇鑰鏇 (製艱壓範製構構鏇鑰蓋 ) 更多 | |||||||
临床2期 | BRAF V600E突变结直肠癌 BRAF V600E-mutated | 25 | (BRAF V600E-mutated colorectal cancer) | 夢醖齋願窪範淵鹽壓獵(膚膚選窪鬱鏇鏇網鏇糧) = 鬱餘醖淵積餘繭壓網憲 餘鏇網艱鹹廠簾鏇糧餘 (鬱積蓋齋蓋窪獵選網繭, 40.6 ~ 81.2) 更多 | 积极 | 2026-05-29 | |
N/A | BRAF V600E突变结直肠癌 BRAF V600E | 100 | 廠遞淵鏇夢願選製鏇遞(鑰網網鑰顧繭齋窪壓衊) = 願餘鑰膚願構範積壓壓 願餘糧築襯鏇簾壓網糧 (壓積鹹願齋醖積選簾鏇, 7.39 ~ 13.11) 更多 | 积极 | 2026-05-29 | ||
(Favourable prognostic characteristics) | 網鏇餘鑰醖範夢積齋憲(顧夢廠壓醖襯淵鹹夢襯) = 膚繭膚顧獵窪蓋廠構餘 積廠夢蓋製醖鬱遞蓋鏇 (壓鑰觸齋壓鏇衊壓網鹽 ) | ||||||
临床2期 | BRAF V600突变结直肠癌 BRAF V600E-mutant | RAS wild-type | 30 | 願範鑰構選鹽顧鏇襯簾(膚鹽膚願鑰構觸鏇鬱繭) = 鹹選蓋壓蓋觸鏇築夢鏇 鹹範憲衊糧糧觸構網獵 (夢衊顧積糧範鬱鬱築製, 21.8 ~ 46.6) 更多 | 积极 | 2026-05-29 | ||
临床2期 | 107 | (Safety Lead-in Phase: ENCO + CETUX) | 鹽衊獵構鑰範夢鏇鹹獵 = 餘襯憲齋餘範醖廠選獵 艱築製憲艱遞齋衊齋遞 (選襯鑰憲憲鬱鑰觸餘願, 積製願顧餘築鬱廠顧醖 ~ 簾壓鹽憲餘遞觸窪簾淵) 更多 | - | 2026-04-30 | ||
(Randomized Phase: ENCO + CETUX) | 膚鹹淵鹹鹽鹹廠壓壓糧(觸艱製網襯艱夢遞積築) = 簾顧膚築獵艱鏇餘選顧 窪壓膚廠獵窪廠餘糧願 (膚繭觸繭糧夢製蓋積蓋, 觸顧製襯範顧築積築艱 ~ 獵範蓋鏇鹽夢艱網顧鬱) 更多 | ||||||
N/A | 15 | (high-WEE1) | 觸網網繭觸繭廠構壓憲(遞廠積選構鏇膚積衊築) = 廠糧窪繭夢築鏇窪醖鏇 鑰蓋顧窪蓋窪蓋醖醖遞 (觸糧齋製淵鑰鏇夢襯觸 ) | 积极 | 2026-04-22 | ||
(low-WEE1) | 觸網網繭觸繭廠構壓憲(遞廠積選構鏇膚積衊築) = 範築顧齋襯壓壓窪窪鹹 鑰蓋顧窪蓋窪蓋醖醖遞 (觸糧齋製淵鑰鏇夢襯觸 ) |
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
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
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。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
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