Multicenter Investigator-initiated Phase II Trial of E7090 in Patients With Advanced or Recurrent Solid Tumor With Fibroblast Growth Factor Receptor (FGFR) Gene Alteration (FORTUNE Trial)

This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).

开始日期2021-06-15

申办/合作机构

National Cancer Center Research Institute

[+1]

JPRN-jRCT2031210043

/ Recruiting临床2期

Multicenter investigator-initiated phase II trial of E7090 in patients with advanced or recurrent solid tumor with fibroblast growth factor receptor (FGFR) gene alteration (FORTUNE trial)

开始日期2021-06-15

申办/合作机构-

JPRN-JapicCTI-205429

/ Recruiting临床1期

An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer

开始日期2020-10-21

申办/合作机构

Eisai Co., Ltd.

100 项与琥珀酸他舒替尼相关的临床结果

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100 项与琥珀酸他舒替尼相关的转化医学

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100 项与琥珀酸他舒替尼相关的专利（医药）

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项与琥珀酸他舒替尼相关的文献（医药）

2026-05-01·Gan to kagaku ryoho. Cancer & chemotherapy

[FGFR2 Fusion Gene-Positive Solid Tumors].

Article

作者: Kawakatsu, Shoji ; Baba, Taisuke ; Kurimoto, Keisuke ; Yamada, Mihoko ; Ebata, Tomoki ; Watanabe, Nobuyuki ; Onoe, Shunsuke ; Mizuno, Takashi ; Sunagawa, Masaki ; Kokuryo, Toshio

Fibroblast growth factor receptors (FGFR) are tyrosine kinases that regulate cellular responses including proliferation, survival, and migration. FGFR fusion genes arose from chromosomal translocations or deletions, lead to ligand-independent constitutive signal activation and contribute to carcinogenesis and cancer progression. FGFR2 fusion genes are identified in 7.4-13.6% of intrahepatic cholangiocarcinoma and 3.6% of perihilar cholangiocarcinoma. They are also reported in colorectal, prostate, and breast cancers, though at lower frequencies. Diagnosis methods are RT-PCR, RNA sequencing, FISH, and NGS. Comprehensive genomic profiling (CGP) tests are available clinically. Three FGFR inhibitors are currently approved. Pemigatinib (approved in 2021) demonstrated a response rate of 35.5%, futibatinib (approved in 2023) showed a response rate of 42%, and tasurgratinib (approved in 2024) achieved a response rate of 30.2%. The most common adverse event is hyperphosphatemia. Alopecia, diarrhea, nail disorders, and retinal detachment are also required attention. Polyclonal on-target resistance to pan-FGFR inhibitors and increasing of FGFR2 kinase domain resistance mutations based on treatment history has been reported. Novel therapeutics, such as highly selective FGFR2 inhibitors and next-generation inhibitors, are developed and are expected to improve prognosis for patients with FGFR2 fusion-positive solid tumors.

2025-12-01·Oncology and Therapy

Sequential Fibroblast Growth Factor Receptor Inhibition in Intrahepatic Cholangiocarcinoma: Navigating an Evolving Landscape of Resistance and Opportunity—A Case Report and Current Opinion

Article

作者: Yamaguchi, Hironori ; Sasanuma, Hideki

Fibroblast growth factor receptor (FGFR)2 rearrangements define a distinct molecular subset of intrahepatic cholangiocarcinoma (iCCA) with therapeutic potential using FGFR inhibitors. However, acquired resistance invariably limits long-term efficacy, posing a significant clinical challenge. Sequential targeting with different FGFR inhibitors is an emerging strategy, yet robust evidence, particularly for third-line and beyond, is scarce, and a consensus on optimal sequencing and patient selection remains unreached. Here, we report a case of FGFR2-rearranged iCCA where the patient achieved a radiographic partial response (PR) to tasurgratinib (a third-line FGFR inhibitor) following prior progression on pemigatinib and futibatinib. This case underscores the sustained dependency on the FGFR pathway and highlights the potential clinical utility of rationally sequenced FGFR-targeted therapy even after multiple lines of treatment. More broadly, this report serves as a basis for a current opinion on the evolving landscape of sequential FGFR inhibition in iCCA. We delve into the complexities of acquired resistance, dissect the arguments for and against prolonged FGFR pathway blockade, explore the impact of co-occurring genomic alterations, discuss the controversies, research priorities, and the urgent need for a balanced perspective to guide future clinical practice and trial design in this rapidly advancing but still uncertain field.

2025-11-08·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Tasurgratinib (E7090) for cholangiocarcinoma with fibroblast growth factor receptor 2 fusions/rearrangements: a multicenter, open-label, Phase 2 study

Article

作者: Ikeda, Masafumi ; Duan, Huaxin ; Yan, Sheng ; Kuwahara, Takamichi ; Nakai, Yousuke ; Satoh, Taroh ; Nakada, Takuya ; Meng, Zhiqiang ; Funasaka, Setsuo ; Shen, Lin ; Furuse, Junji ; Komatsu, Yoshito ; Morizane, Chigusa ; Ma, Xuelei ; Ikezawa, Hiroki ; Ueno, Makoto ; Cui, Tongjian ; Zhao, Haitao ; Sasaki, Takashi ; Nagano, Hiroaki

Abstract:

Background:

This Phase 2 study (NCT04238715) evaluated the efficacy/safety of tasurgratinib 140 mg daily in patients with cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) 2 fusions/rearrangements.

Methods:

Eligible Japanese and Chinese patients who had surgically unresectable, advanced, or metastatic CCA and had received ≥1 prior gemcitabine-based combination chemotherapy regimen were included and treated with oral tasurgratinib 140 mg daily. The primary endpoint was objective response rate (ORR); the study was considered successful if the lower limit of the ORRs 90% CI was >15%. Secondary endpoints included duration of response and safety. FGFR2 fusions/rearrangements were confirmed by fluorescence in situ hybridization performed in central laboratories. Tumor responses were measured every 8 weeks by Response Evaluation Criteria in Solid Tumors version 1.1 per independent imaging review.

Results:

Sixty-three patients were treated; 23 (37%) had received 1 prior regimen, all others had received ≥2. By the data cutoff date (15 March 2023), the ORR was 30.2% (two-sided 90% CI: 20.7–41.0). The median duration of response for responders was 5.6 months (95% CI: 3.7–9.3; range: 1.0+ to 14.8+). Sixty-one patients (97%) had ≥1 treatment-related treatment-emergent adverse event; 18 patients (29%) had ≥1 grade ≥3 treatment-related treatment-emergent adverse events. Four patients (6%) had a fatal adverse event, none were considered treatment-related. Tasurgratinib had promising antitumor activity in patients with CCA harboring FGFR2 fusions or rearrangements after ≥1 prior gemcitabine-based chemotherapy regimen.

Conclusions:

The primary endpoint (ORR) met the study’s predefined success criteria. Tasurgratinib had a manageable safety profile consistent with previous reports and the known pharmacological profile of FGFR inhibitors.

项与琥珀酸他舒替尼相关的新闻（医药）

2026-10-13

·知乎专栏

2026年9月国内外[NMPA&FDA]获批新药大盘点

2026年9月，NMPA批准上市了10款新药(仅包含1类新药/治疗用生物制品3.1类/化药5.1类)，具体为：库莱韦单抗作用机制：靶向RSV F蛋白的长效预防性单抗适应症：用于即将进入或出生在第一个呼吸道合胞病毒（RSV）流行季的新生儿和婴儿预防RSV所致的下呼吸道感染芮特韦拜单抗作用机制：靶向RSV F蛋白的长效预防性单抗适应症：用于即将进入或出生在第一个呼吸道合胞病毒（RSV）流行季的新生儿和婴儿预防RSV所致的下呼吸道感染艾曲帕米鼻喷雾剂作用机制：新型钙通道阻滞剂适应症：用于成人阵发性室上性心动过速（PSVT）急性发作时转复窦性心律利扎布替尼片作用机制：BTK抑制剂适应症：用于既往糖皮质激素、免疫球蛋白等治疗效果不佳，或是无法耐受上述治疗的持续性、慢性原发免疫性血小板减少症（ITP）成人患者醒脾解郁片作用机制：中药适应症：用于轻、中度抑郁症，症见情绪郁闷、低落，表情淡漠、倦怠乏力、失眠多梦、少气懒言、食少纳呆，头重肢困、口中粘腻、面色晦暗，舌淡苔白腻或灰腻、脉滑或弦注射用伏索利肽作用机制：C型利钠肽（CNP）类似物适应症：治疗骨骺未闭合的 4 月龄及以上患者的软骨发育不全（诊断应经基因检测确认）琥珀酸他舒替尼片作用机制：FGFR 酪氨酸激酶抑制剂适应症：用于既往化疗失败、经检测确认携带 FGFR2 融合 / 重排的不可切除胆管癌患者塞普替尼片作用机制：RET抑制剂适应症：推测沿用胶囊剂型在中国获批的3个适应症（RET融合阳性非小细胞肺癌，RET突变型甲状腺髓样癌，RET融合阳性甲状腺癌）甲磺酸亮丙瑞林注射液（6M）作用机制：GnRHa类长效制剂适应症：用于晚期前列腺癌的雄激素去势治疗（ADT）盐酸艾泊度胺胶囊机制：Cereblon 调节性蛋白降解剂适应症：该药联合达雷妥尤单抗和地塞米松适用于治疗既往接受过至少一线治疗（包括一种蛋白酶体抑制剂和一种免疫调节剂）的多发性骨髓瘤成人患者与此同时，FDA公布了9款首次获批的创新药（仅含新分子实体和新生物制剂）。亮点唯一治疗亚历山大病新药获批--zilganersen全球首个ctDNA指导的口服SERD获FDA批准--camizestrant全球首款用于 SMA 肌肉靶向疗法获批--apitegromab-mstn首款用于胶质瘤的 FET-PET 显像剂获FDA批准--floretyrosine F 182型糖尿病新增每周1次基础胰岛素治疗选择--insulin efsitora alfa-gobe美国首个FGFR2选择性胆管癌靶向药获批--lirafugratinib全球首个用于帕金森病治疗的选择性 D1/D5 受体部分激动剂获批--tavapadon首款口服 ALK2 抑制剂获批治疗 FOP--zilurgisertib美国首个MCT8缺乏症治疗药物获批--tiratricol中国NMPA批准的10款新药List：FDA批准的9款新分子实体/新生物制剂（不含新增适应症）List：我们会在每个月上线国内外（NMPA&FDA）获批新药盘点，敬请期待！期待2026年有更多好药新药获批上市，为众多患者带来更多希望和生命之光！*以上内容仅供专业人士参考数据来源：以上数据均来自NMPA和FDA官网。点击下方小程序卡片，了解更多在研新药临床捷信医药成立于2008年，是国内领先的数字化患者解决方案企业，也是亚洲患者招募组织发起人之一。公司专注临床研究患者招募及管理，覆盖城市230多个，服务项目1700个，在 250多个疾病领域积累了成功经验，助力100多个新药在中国上市。公司具有领先的数字化业务体系，具有成熟的全渠道推广及招募管理经验。公司自有平台“新药之光"——以患者为中心的临床研究服务平台，致力于患者招募、患者保留及依从性管理、患者访谈与调研、患教活动及直播、视频策划与制作(包括临床研究推广和普及、项目宣传、疾病领域科普和教育、故事和生命教育等)、全平台内容推广(大V医生、垂直博主和素人)、大平台内容收录与优化。同时，公司持续研发创新，推出以AI赋能的临床研究项目协同平台，包括AI自动脱敏、AI辅助筛选，协同讨论等模块，更好地联结各方，精准匹配，提高效率。捷信作为研发型药企优选供应商，我们连接大众端、患者端、医生端、研究机构，保障临床研究试验高质量合规入组，实现从患者移动端报名到入组的多方在线协同，为企业用户提供数字化解决方案。9月新药盘点 #RSV预防单抗 #芮特韦拜单抗 #库莱韦拜单抗 #软骨发育不全 #FGFR2#融合胆管癌 #琥珀酸他舒替尼片 #阵发性室上性心动过速鼻喷用药 #艾曲帕米鼻喷雾剂 #盐酸艾泊度胺胶囊 #帕金森病

2026-09-08

·i Hope医学

9月8日肿瘤临床研究进展日报

今日要闻NMPA 批准恩沙替尼用于 ALK 阳性非小细胞肺癌术后辅助治疗，为国产首款英文原文：China NMPA approves ensartinib (Ensacove) as adjuvant therapy for ALK-positive NSCLC, first domestic ALK inhibitor in this indication 进展要点：贝达药业 9 月 3 日获 NMPA 注册证书，II-IIIB 期患者 2 年 DFS 86.4% vs 安慰剂 53.5%，复发风险降低 80%；2026 版 CSCO 指南已纳入 IB 期术后辅助唯一推荐。NMPA 附条件批准甲磺酸氘申艾替尼片（卡达沙）一线治疗伴 CNS 转移的 EGFR 突变 NSCLC 英文原文：China NMPA conditionally approves deuterated aumolertinib mesylate (Kadasa) as first-line for EGFR-mutant NSCLC with CNS metastases 进展要点：8 月 31 日浙江同源康医药获批，针对 19DEL/L858R 突变伴中枢神经系统转移的局部晚期或转移性 NSCLC，颅内 ORR 达 95.5%。FDA 加速批准 camizestrant（Etcamah）联合 CDK4/6 抑制剂治疗 ESR1 突变 HR+/HER2- 晚期乳腺癌英文原文：FDA grants accelerated approval to camizestrant with CDK4/6 inhibitor for ESR1-mutated HR+/HER2- advanced breast cancer 进展要点：9 月 4 日获批，基于 SERENA-6 III 期研究；中位 PFS 16 个月 vs 9.2 个月，HR 0.44；AstraZeneca 同步拿下 Guardant360 CDx 伴随诊断。和黄医药与GSK 就 KRAS-EGFR 抗体靶向治疗偶联物 HMPL-A830 达成 12.95 亿美元海外授权英文原文：HUTCHMED and GSK sign $1.295B licensing deal for KRAS-EGFR antibody-targeted therapy conjugate HMPL-A830 进展要点：首付款 1.1 亿美元 + 11.85 亿美元里程碑款；适应症聚焦结直肠癌、胰腺导管腺癌、肺腺癌（KRAS 突变率 44% / 89% / 34%）；HUTCHMED 保留大中华区权益。EMERALD-3 III 期：STRIDE 方案联合仑伐替尼 + TACE 治疗不可切除 HCC，PFS 风险降低 30% 英文原文：EMERALD-3 Phase 3: STRIDE regimen + lenvatinib + TACE cuts progression risk by 30% in unresectable HCC 进展要点：AstraZeneca EMERALD-3 报告，度伐利尤单抗+曲麦利尤单抗+仑伐替尼+TACE vs TACE：中位 PFS 13.0 vs 9.8 个月，HR 0.70；OS 呈现阳性趋势（HR 0.84）。新注册/ 更新临床试验（ClinicalTrials.gov）NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) 中文标题：CEA-PRIT 2.0 在转移性结直肠癌（mCRC）患者中的研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Metastatic Colorectal Cancer 申办方/ 更新日期：Hoffmann-La Roche · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07416552NCT07252297 — The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer 中文标题：通用肿瘤标志物 SIX6 在诊断非肌层浸润性膀胱癌中的作用分期/ 状态：NA · ACTIVE_NOT_RECRUITING 瘤种/ 干预：Non-muscle Invasive Bladder Cancer 申办方/ 更新日期：Xijing Hospital · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07252297NCT01972919 — MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer 中文标题：MR 引导下 II 期放疗剂量递增治疗不可切除非转移性胰腺癌分期/ 状态：PHASE2 · COMPLETED 瘤种/ 干预：Unresectable Pancreatic Cancer 申办方/ 更新日期：Medical College of Wisconsin · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT01972919NCT07361562 — A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors 中文标题：选择性 ERBB2 抑制剂 CGT4255 在晚期实体瘤患者中的研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2 申办方/ 更新日期：Cogent Biosciences, Inc. · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07361562NCT06062498 — Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer 中文标题：Elacestrant 单药 vs 联合 CDK4/6 抑制剂治疗 ER+/HER2- 晚期或转移性乳腺癌分期/ 状态：PHASE2 · RECRUITING 瘤种/ 干预：Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer 申办方/ 更新日期：Northwestern University · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT06062498NCT06364410 — Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors 中文标题：德曲妥珠单抗（DS-8201a）联合 Azenosertib（ZN-c3）治疗胃癌或其他实体瘤的临床研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Gastric Carcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Locally Advanced Malignant Solid Neoplasm, Metastatic Gastric Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Solid Neoplasm, Unresectable Gastric Carcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma, Unresectable Malignant Solid Neoplasm 申办方/ 更新日期：National Cancer Institute (NCI) · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT06364410顶刊论文The Lancet Oncology ·An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial. — 综合生活方式干预缓解前列腺癌雄激素剥夺治疗相关不良反应的STAMINA 多中心随机试验（PMID 42697217，2026 Sep 4）。 ·Exercise oncology: from trials and guidelines to routine clinical care. — 运动肿瘤学：从临床试验与指南走向常规临床实践（PMID 42697216，2026 Sep 4）。 ·Delays in cancer referrals and care lead to harm and missed diagnoses in England. — 英格兰地区癌症转诊与诊疗延误导致伤害与漏诊（PMID 42660162，2026 Aug 27）。Journal of Clinical Oncology ·Breast Cancer Risk Assessment Has a Data Integration Problem: Can Artificial Intelligence Solve It? — 乳腺癌风险评估面临数据整合难题：人工智能能否破解？（PMID 42696695，2026 Sep 4）。 ·International Breast Cancer Trials and Optimal Sequence of Treatment. — 国际乳腺癌临床试验与最佳治疗顺序（PMID 42696689，2026 Sep 4）。 ·Daraxonrasib in Pancreatic Cancer: From Second-Line Breakthrough to First-Line Evidence. — Daraxonrasib 治疗胰腺癌：从二线突破到一线循证（PMID 42691452，2026 Sep 3）。 ·Molecularly Guided Therapy Versus Continued Chemotherapy in Unfavorable Cancer of Unknown Primary: Updated Efficacy and Safety From the Randomized, Phase II CUPISCO Study. — 分子指导治疗vs 继续化疗治疗不良预后原发不明癌：随机 II 期 CUPISCO 研究最新疗效与安全性更新（PMID 42691436，2026 Sep 3）。 ·Bridging the Gap: Mounting Evidence for Metastasis-Directed Therapy in Oligometastatic Disease. — 弥合差距：寡转移性疾病转移定向治疗证据日益充实（PMID 42685304，2026 Sep 2）。JAMA Oncology ·Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. — 新辅助Anbenitamab 联合 HB1801 治疗 ERBB2 阳性乳腺癌：III 期随机临床试验（PMID 42690668，2026 Sep 3）。 ·Incidental SDHA Variant Diagnosis-A Cancer Geneticist's Viewpoint as a Patient. — Incidental SDHA Variant Diagnosis-A Cancer Geneticist's Viewpoint as a Patient.（PMID 42690657，2026 Sep 3）。会议摘要（ASCO 2026 重磅 LBA） ·LIBRETTO-432: Adjuvant selpercatinib in IB-IIIA RET fusion-positive NSCLC, EFS HR 0.172 in stage II-IIIA — LIBRETTO-432：selpercatinib 辅助治疗 IB-IIIA 期 RET 融合 NSCLC，II-IIIA 期 EFS HR 0.172（LBA3, ASCO 2026）。 ·PROTEUS: Perioperative apalutamide + ADT in high-risk localized prostate cancer, dual primary endpoints met — PROTEUS：高危局限性前列腺癌围手术期 apalutamide + ADT，pCR/MFS 双终点阳性（LBA1, ASCO 2026）。 ·SARC041: Abemaciclib vs placebo in dedifferentiated liposarcoma, PFS 9.67 vs 1.52 months — SARC041：abemaciclib vs 安慰剂治疗去分化脂肪肉瘤，PFS 9.67 vs 1.52 个月（LBA2, ASCO 2026）。 ·HARMONi-6: Ivonescimab + chemo vs tislelizumab + chemo in untreated advanced squamous NSCLC, OS 27.9 vs 23.7 months — HARMONi-6：ivonescimab + 化疗 vs tislelizumab + 化疗治疗初治晚期鳞状 NSCLC，OS 27.9 vs 23.7 个月（LBA4, ASCO 2026）。 ·RASolute 302: Daraxonrasib vs chemo in previously treated mPDAC, primary and final analysis positive — RASolute 302：daraxonrasib vs 化疗治疗既往治疗 mPDAC，主要终点阳性（LBA5, ASCO 2026）。 ·EMERALD-3: STRIDE ± lenvatinib + TACE in unresectable embolization-eligible HCC — EMERALD-3：STRIDE 方案 ± lenvatinib + TACE 治疗可栓塞不可切除 HCC（LBA4000, ASCO 2026）。 ·SERENA-6: First-line camizestrant + CDK4/6i for emergent ESR1 mutation in aBC, final PFS2 results — SERENA-6：camizestrant + CDK4/6 抑制剂在 ESR1 突变 aBC 一线治疗的最终 PFS2 数据（LBA1007, ASCO 2026）。 ·VIKTORIA-1: Gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- PIK3CA-mutant aBC — VIKTORIA-1：gedatolisib + fulvestrant ± palbociclib vs SOC 治疗 HR+/HER2- PIK3CA 突变 aBC（LBA1008, ASCO 2026）。PubMed 最新实体瘤文献 ·Engineered Natural Killer Cell Derived-Extracellular Vesicles: An Acellular Immunotherapy with Cytotoxic Effects in SNU-1079 Human Cholangiocarcinoma Cells. — 工程化自然杀伤细胞来源细胞外囊泡：一种对SNU-1079 人胆管癌细胞具细胞毒性的非细胞免疫疗法（Molecular pharmaceutics，PMID 42704135，2026 Sep 7）。 ·Organ-specific response to atezolizumab + bevacizumab combination therapy for unresectable hepatocellular carcinoma with extrahepatic metastases: a retrospective cohort study. — 阿替利珠单抗+ 贝伐珠单抗联合治疗伴肝外转移的不可切除肝细胞癌的器官特异性反应：回顾性队列研究（Journal of gastrointestinal oncology，PMID 42703494，2026 Aug 31）。 ·Tumor border delineation in basal cell carcinoma using Fourier analysis. — Tumor border delineation in basal cell carcinoma using Fourier analysis.（Lasers in medical science，PMID 42702677，2026 Sep 7）。 ·CRISPR-Engineered CAR-T Cell Therapy for Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma: A Review of Emerging Therapeutic Prospects. — CRISPR 工程化 CAR-T 细胞疗法治疗 EB 病毒相关鼻咽癌：新兴治疗前景综述（Reviews in medical virology，PMID 42700448，2026 Sep）。 ·PET Imaging of Tumor-Associated Macrophage Dynamics and Response to Clinical Treatment for Potential Translation. — 肿瘤相关巨噬细胞动态及临床治疗反应的PET 显像：转化潜力评估（Journal of nuclear medicine : official publication, Society of Nuclear Medicine，PMID 42692828，2026 Sep 3）。 ·Brain metastasis: Opportunities for novel therapies. — 脑转移瘤：新疗法的探索机遇（Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics，PMID 42691591，2026 Sep 3）。监管动态（FDA / NMPA）FDA 批件：FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors 中文：FDA 正式批准 selpercatinib 用于既往治疗后进展的局部晚期或转移性 RET 融合阳性实体瘤药物/ 日期：RETEVMO (Selpercatinib) · 2026-07-14 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret 批件：FDA approves zanidatamab-hrii + tislelizumab-jsgr for first-line HER2-positive gastric/GJ/esophageal adenocarcinoma 中文：FDA 批准 zanidatamab-hrii 联合 tislelizumab-jsgr 用于 HER2 阳性晚期胃/胃食管交界/食管腺癌一线治疗药物/ 日期：ZIIHERA (Zanidatamab-hrii) · 2026-08-25 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric 批件：FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma 中文：FDA 批准 daraxonrasib 用于既往治疗后或不适合多药系统治疗的转移性胰腺导管腺癌药物/ 日期：RASONQUE (Daraxonrasib) · 2026-08-26 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma 批件：FDA grants accelerated approval to camizestrant + CDK4/6 inhibitor for ESR1-mutated HR+/HER2- breast cancer 中文：FDA 加速批准 camizestrant 联合 CDK4/6 抑制剂治疗 ESR1 突变 HR+/HER2- 晚期乳腺癌药物/ 日期：ETCAMAH (Camizestrant) · 2026-09-04 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negativeNMPA（中国国家药监局）批件：China NMPA conditionally approves van-deglafenib (爱领达, Hutchmed) for FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma 中文：NMPA 附条件批准和记黄埔医药凡瑞格拉替尼片（爱领达）用于 FGFR2 融合/重排的晚期肝内胆管癌日期：2026-08-31 链接：https://www.toutiao.com/article/7680386024190591523 批件：China NMPA approves Hengrui raylolizumab trastuzumab (Rui Kang, Aiweida®) for HER2-positive colorectal cancer 中文：NMPA 批准恒瑞 HER2 ADC 瑞康曲妥珠单抗（艾维达®）用于经奥沙利铂/氟尿嘧啶/伊立替康失败的 HER2 阳性结直肠癌，国内首个 HER2 CRC 适应症日期：2026-08-中旬链接：https://www.cnfin.com/announ/detail/index.html?id=839366390666 批件：China NMPA approves bevacizumab + anlotinib sequential chemo for first-line locally advanced or metastatic squamous NSCLC 中文：NMPA 批准中国生物制药贝莫苏拜单抗联合安罗替尼序贯化疗一线治疗局部晚期或转移性鳞状 NSCLC 日期：2026-08-07 链接：https://www.zyzhan.com/news/detail/100024.html 批件：China NMPA approves tasurgratinib (替恩戈替尼, Transcenta) for pretreated FGFR2 fusion cholangiocarcinoma 中文：NMPA 批准药捷安康捷恩泰®（替恩戈替尼）用于 FGFR 抑制剂治疗失败且 FGFR2 融合/重排的晚期胆管癌日期：2026-08-06 链接：https://www.zyzhan.com/news/detail/100024.html 批件：China NMPA approves ensartinib (Ensacove, Betta) for adjuvant therapy in ALK-positive stage IB-IIIB NSCLC 中文：NMPA 批准贝达药业恩沙替尼（贝美纳）用于 ALK 阳性 IB-IIIB 期 NSCLC 术后辅助治疗，国产首款 ALK 辅助适应症日期：2026-09-03 链接：https://news.qq.com/rain/a/20260903A08TIF00药企公告（实体瘤方向） ·Evotec and Plectonic enter research collaboration on next-generation T-cell-engaging therapies for solid tumors — Evotec 与 Plectonic 达成新一代 T 细胞接合器实体瘤免疫疗法研究合作（来源：药企新闻稿）。链接：https://www.gurufocus.com/news/9063524/evotec-and-plectonic-enter-research-collaboration-to-explore-new-generation-of-tcellengaging-approaches-for-solid-tumors ·GSK licenses HUTCHMED's solid-tumor conjugate HMPL-A830 in up to $1.3B deal — GSK 引进和黄医药 KRAS-EGFR 抗体靶向治疗偶联物（HMPL-A830），总金额高达 12.95 亿美元（来源：药企新闻稿）。链接：https://www.pharmaceutical-technology.com/news/gsk-licenses-hutchmeds-solid-tumour-conjugate-in-up-to-1-3bn-deal/ ·Styx Biotechnologies signs strategic agreement with ZoeNCure Therapeutics to advance ADC pipeline to clinic — Styx Biotechnologies 与 ZoeNCure Therapeutics 达成战略合作，加速 ADC 管线进入首次人体临床研究（来源：药企新闻稿）。链接：https://www.morningstar.com/news/business-wire/20260901406609/styx-biotechnologies-announces-strategic-agreement-with-zoencure-therapeutics-to-accelerate-next-generation-adc-pipeline-to-clinic

2026-09-08

·药研苑

赛生药业FGFR抑制剂他舒替尼获批用于胆管癌

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年9月3日赛生药业宣布，琥珀酸他舒替尼片已获得国家药品监督管理局（NMPA）批准，用于既往化疗后失败的，且经检测确认具有FGFR2融合/重排基因的，不可切除的胆管癌患者的治疗。本次获批基于多中心、开放标签、单臂2期临床试验E7090-J000-201的研究结果。E7090-J000-201研究共纳入63名不可切除，既往接受≥1线含吉西他滨化疗方案治疗的FGFR2融合/重排晚期或转移性胆管癌患者。截至2025年5月27日，中位随访时间为38个月，经独立影像学评估的客观缓解率（ORR）为31.7%。其中，中国人群的客观缓解率（ORR）为37.1%，总生存期（OS）为20.1个月。他舒替尼（Tasurgratinib）为选择性成纤维细胞生长因子（FGFR）1、2和3抑制剂，由卫材开发。成纤维细胞生长因子突变是肿瘤的驱动因素。目前国内获批的FGFR抑制剂还包括凡瑞格拉替尼（Fanregratinib）、佩米替尼（FGFR1、2和3抑制剂）和厄达替尼（FGFR1、2、3和4抑制剂），厄达替尼还可以与RET、CSF1R、PDGFRA、PDGFRB、FLT4、KIT和 VEGFR2结合。凡瑞格拉替尼、佩米替尼与他舒替尼类似，均已获批用于胆管癌。推荐指数：★★ 推荐原因：他舒替尼获批为胆管癌患者提供新的治疗选择，也有助于促进FGFR抑制剂在胆管癌领域的市场发展。个人观点，仅限参考。相关阅读：超越非布司他？一品红降尿酸药物氘泊替诺雷3期研究达到终点贝达药业恩沙替尼获批用于非小细胞肺癌术后辅助治疗 PD-1抑制剂帕博利珠单抗获批用于围手术期局部晚期头颈鳞癌箕星药业艾曲帕米鼻喷雾剂获批用于阵发性室上性心动过速恒瑞医药抗IL-4Rα卓托奇拜单抗申请上市用于中重度特应性皮炎 B7-H3靶向ADC依康坦博妥塔单抗申请上市用于小细胞肺癌翰森制药B7-H3靶向ADC（HS-20093）申请上市用于小细胞肺癌卫材抗阿尔茨海默病单抗仑卡奈单抗获批皮下自动注射剂齐鲁制药糠酸氟替卡松鼻用喷雾剂首仿获批上市恒瑞口服小分子GLP-1药物HRS-7535申请上市用于2体重管理一线治疗晚期胃食管癌3期研究，总生存期泽尼达妥超曲妥珠息肉状脉络膜血管病变3b/4期试验，法瑞西2年研究数据发布恒瑞口服小分子GLP-1药物HRS-7535申请上市用于2型糖尿病艾尔建含利多卡因注射用交联透明质酸钠凝胶获批改善口周皱纹相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

100 项与琥珀酸他舒替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12404	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
FGFR2融合或重排的胆管癌	日本	Eisai Co., Ltd.	2024-09-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
中枢神经系统肿瘤	临床2期	日本	Eisai Co., Ltd.	2021-06-15
肝内胆管癌	临床2期	日本	Eisai Co., Ltd.	2021-06-15
肝转移	临床2期	日本	Eisai Co., Ltd.	2021-06-15
复发性实体肿瘤	临床2期	日本	Eisai Co., Ltd.	2021-06-15
转移性胆管癌	临床2期	中国	Eisai Co., Ltd.	2020-01-22
转移性胆管癌	临床2期	日本	Eisai Co., Ltd.	2020-01-22
ER阳性/HER2阴性乳腺癌	临床1期	日本	Eisai Co., Ltd.	2020-10-09
ER阳性乳腺癌	临床1期	日本	Eisai Co., Ltd.	2020-10-09
晚期恶性实体瘤	临床1期	日本	Eisai Co., Ltd.	2014-10-28
不能切除的胆道癌	临床申请批准	中国	Eisai Co., Ltd.	2026-06-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


JPRN-jRCT2031210043 (FORTUNE, SNO2025)	临床2期	FGFR突变肿瘤 \| 脑癌 FGFR1-3 fusion \| FGFR1-3 mutation sensitive to tasurgratinib by MANO methods \| FGFR1-3 activating mutation not in Group B or FGFR1/2 amplification ... 更多	41	Tasurgratinib 140 mg QD (FGFR1-3 fusion)	鑰顧鹹鹽觸糧鏇餘壓製(衊餘鬱衊壓範齋艱襯夢) = 憲鹹製簾顧糧範鏇範鬱簾蓋鑰壓壓鹹壓鹽願鹽 (淵淵淵襯鹽夢遞範餘範 ) 更多	积极	2025-11-19
				Tasurgratinib 140 mg QDtasurgratinib (FGFR1-3 mutation sensitive to tasurgratinib by MANO methods)	鑰顧鹹鹽觸糧鏇餘壓製(衊餘鬱衊壓範齋艱襯夢) = 鹹獵膚顧憲夢選襯壓範簾蓋鑰壓壓鹹壓鹽願鹽 (淵淵淵襯鹽夢遞範餘範 ) 更多
NCT04962867 (FORTUNE study, ASCO2025)	临床2期	FGFR突变肿瘤	46	tasurgratinib (E7090) (Group A: FGFR1-3 fusion)	襯繭鑰壓醖憲築顧願廠(鬱鬱壓遞鬱膚蓋製構鹹) = 憲蓋鹹範觸齋壓鹽遞廠遞鹽簾遞襯範艱醖衊選 (鹹窪願選鏇醖襯壓鹽繭, 3.7 ~ 50.7) 更多	积极	2025-05-30
				tasurgratinib (E7090) (Group B: FGFR1-3 sensitive mutations to tasurgratinib determined by MANO methods)	襯繭鑰壓醖憲築顧願廠(鬱鬱壓遞鬱膚蓋製構鹹) = 鹹壓範鬱醖衊構齋醖遞遞鹽簾遞襯範艱醖衊選 (鹹窪願選鏇醖襯壓鹽繭, 5.7 ~ 44.0) 更多
NCT04572295 (Study 102, ASCO2024) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌二线 HER2 Negative \| ER Positive	32	E7090 + FUL	獵遞蓋壓糧簾鹽網選範(願鬱壓願襯醖窪齋襯構) = 製鑰選夢築餘構窪鏇獵鏇鹹鏇襯窪積蓋鬱淵繭 (齋網構願簾獵膚製廠繭 ) 更多	积极	2024-05-24
				E7090 105 mg + FUL 500 mg	獵遞蓋壓糧簾鹽網選範(願鬱壓願襯醖窪齋襯構) = 積獵齋廠選顧網網廠遞鏇鹹鏇襯窪積蓋鬱淵繭 (齋網構願簾獵膚製廠繭 ) 更多
NCT04238715 (ASCO_GI2024) 人工标引	临床2期	FGFR2融合或重排的胆管癌 FGFR2 gene fusion	63	tasurgratinib 140 mg	鏇獵築鹹構糧淵範糧齋(廠繭壓鑰顧簾夢顧鏇廠) = 衊醖衊襯憲憲選齋襯鑰鏇簾蓋顧夢繭簾鬱鹽淵 (顧繭淵鹽衊願鏇觸餘簾 ) 更多	积极	2024-01-19
ASCO_GI2020	临床1期	FGFR2阳性胃癌 \| FGFR2突变胆管上皮癌	16	E7090 (Cholangiocarcinoma harboring FGFR2 gene fusion)	顧夢獵夢繭鹹憲遞淵壓(衊衊蓋襯獵鑰範積選製) = reported in 2 out of 16 patients (13%); they were increased AST, lipase increased and retinopathy 鬱選選遞齋糧製鹽選衊 (壓鏇簾觸積鏇憲夢鬱鹽 ) 更多	积极	2020-02-04
				E7090 (Gastric cancer harboring FGFR2 gene amplification or FGFR2 protein high expression)
NCT02275910 (Pubmed \| Cancer Sci) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	24	E7090	顧憲簾襯鏇壓繭觸膚蓋(願範齋製顧艱遞膚獵鏇) = No DLT were observed up to the 140-mg dose; one patient in the 180-mg cohort experienced a DLT (increased aspartate aminotransferase/alanine aminotransferase, grade 3) 窪齋範壓糧鹽鹹築廠獵 (鹹夢夢簾壓觸壓獵獵憲 )	积极	2020-02-01
NCT02275910 (AACR2017)	临床1期	FGFR2融合或重排的胆管癌	40	E7090	願襯獵鹽齋窪淵襯築積(範鹹鏇衊積糧範壓構衊) = 築衊鑰觸夢遞構鬱蓋襯鬱憲積艱選憲襯鏇憲觸 (築遞鬱壓鹽範醖網範積 )	积极	2017-07-01