紫杉醇(Paclitaxel) - 药物靶点：Tubulin_在研适应症：晚期胃癌，转移性胰腺腺癌，转移性乳腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

EmPAC、LDE-paclitaxel、NanoPac

+ [78]

靶点

Tubulin

作用方式

抑制剂

作用机制

微管蛋白抑制剂

治疗领域

肿瘤感染消化系统疾病+ [12]

在研适应症

晚期胃癌转移性胰腺腺癌转移性乳腺癌+ [207]

非在研适应症

异戊酸血症急性淋巴细胞白血病食管腺癌+ [216]

原研机构

National Institutes of Health

在研机构

Alliance Foundation Trials LLC

National Cancer Institute

NRG Oncology

+ [52]

非在研机构

Hoffmann-La Roche, Inc.

University of Washington

Pfizer Inc.

+ [53]

权益机构

深圳市康哲药业有限公司

沈阳三生制药有限责任公司

Hanmi Pharmaceutical Co., Ltd.

+ [26]

最高研发阶段批准上市

首次获批日期

美国 (1992-12-29),

艾滋病相关性卡波西肉瘤乳腺癌卵巢癌

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)

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结构/序列

分子式C47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS号33069-62-4

关联

2,694

项与紫杉醇相关的临床试验

NCT07594548

/ Not yet recruiting临床1期IIT

A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

开始日期2027-09-09

申办/合作机构

Northwestern University

[+1]

NCT07346196

/ Not yet recruiting临床2期IIT

A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.

开始日期2027-02-07

申办/合作机构

The University of Chicago

NCT07281417

/ Recruiting临床2期IIT

Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.

开始日期2026-11-24

申办/合作机构

National Cancer Institute

100 项与紫杉醇相关的临床结果

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100 项与紫杉醇相关的转化医学

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100 项与紫杉醇相关的专利（医药）

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51,371

项与紫杉醇相关的文献（医药）

2026-12-31·Future Science OA

Clinical efficacy of 2-week and 3-week albumin-bound paclitaxel therapy for advanced pancreatic cancer

Article

作者: Su, Zhimin ; Li, Zhiyong ; Shen, Feng ; Jiang, Jiana

OBJECTIVE:

We aim to compare the clinical efficacy and safety of albumin-bound paclitaxel (nab-PTX) (125 mg/m2, q2w) for two weeks and (125 mg/m2, d1, d8, q3w) for three weeks in the first-line treatment of advanced pancreatic cancer.

METHODS:

The medical records of patients with advanced pancreatic cancer who received nab-PTX for 2 weeks and 3 weeks, combined with gemcitabine, from July 2018 to January 2023, were retrospectively analyzed. The efficacy and adverse reactions of the two groups of patients were compared.

RESULT:

A total of 64 patients were included. The median progression-free survival (mPFS) of the 2-week group was 5.6 months, while the 3-week group was 7.8 months. The median overall survival (mOS) of the 2-week group was 14.0 months, while the 3-week group was 14.7 months. The multivariate analysis showed that a physical fitness status score of 0-1 was an independent factor with better OS, while metastatic sites ≥ 3 were related to poor OS. The incidence of leukopenia or neutropenia, neurotoxicity, fatigue, and poor appetite in the 2-week group was lower than that in the 3-week group.

CONCLUSION:

The clinical efficacy of nab-PTX in the 2-week and dose intensive 3 week did not show significant difference, but the 2-week treatment group had better tolerance and safety.

2026-12-31·ANNALS OF MEDICINE

Comparative effectiveness of percutaneous coronary intervention strategies for coronary small-vessel disease: a network meta-analysis of randomized trials

Review

作者: Du, Zhiyan ; Xu, Yixin ; Wang, ZhiLong ; Fan, Chao ; Jiang, Zhihui ; Wu, Tingting ; Zheng, Yingying ; Lv, Mingming ; Pan, Ying ; Adilijiang, Adilai. ; Bai, Bingxin ; Xie, Xiang ; Deng, Changjiang

BACKGROUND:

Coronary small-vessel disease (SVD) remains challenging for percutaneous coronary intervention (PCI) because small lumens magnify restenosis and ischemic risk. Multiple devices are available, yet their comparative performance is uncertain. This study evaluated and ranked PCI strategies for SVD.

METHODS:

A systematic review and network meta-analysis was conducted in accordance with PRISMA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and Google Scholar were searched from inception to 15 August 2025. Eligible studies were English-language randomized controlled trials enrolling adults with angiographic SVD defined as reference vessel diameter ≤3.0 mm, comparing PCI strategies, and reporting target lesion revascularization (TLR), binary restenosis (BR), or myocardial infarction (MI). A frequentist random-effects network meta-analysis generated odds ratios (ORs) with 95% confidence intervals (CIs) and treatment rankings using the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Thirty-nine trials including 14,503 patients met the criteria. For TLR (37 studies; 11,980 patients), the highest SUCRA values were observed with sirolimus-eluting stents (SES 90.1%), zotarolimus-eluting stents (ZES 83.9%), and everolimus-eluting stents (EES 82.2%). For BR (32; 6,468), SES, ZES, and paclitaxel-coated balloons (DCB-PTX) ranked highest (95.0%, 80.0%, and 78.3%). For MI (37; 11,602), SES, DCB-PTX, and ZES ranked highest (79.0%, 78.7%, and 68.5%). Representative effects showed SES reduced TLR versus bare-metal stents (BMS) (OR, 0.25; 95% CI, 0.15-0.43) and MI versus BMS (OR, 0.41; 95% CI, 0.21-0.79). Conventional approaches such as BMS, plain old balloon angioplasty (POBA), and gold-plated balloon angioplasty (GPBA) ranked lowest across outcomes.

CONCLUSION:

SES provides the most consistent clinical benefit for coronary SVD. ZES, EES, and DCB-PTX are effective alternatives in selected settings, whereas BMS, POBA, and GPBA are less effective. These findings offer comparative evidence to guide device selection in SVD.

2026-12-31·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

作者: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Shechtman, Yelena ; Lepage, Stéphanie ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Bélanger, Karl ; Jamal, Rahima ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

6,703

项与紫杉醇相关的新闻（医药）

2026-06-24

·鼎科医疗

「刻痕药球鼎级守护」多中心手术联播（第四期）圆满落幕聚焦血透通路难题共探刻痕药球临床应用价值

6月23日，「刻痕药球鼎级守护」多中心手术联播（第四期）线上学术会议圆满举办。本次活动聚焦血透通路临床诊疗痛点，普及规范化操作理念，推广以刻痕药球为代表的创新介入器械与诊疗技术，进一步提升国内血液透析通路疾病整体诊疗水平。本次会议由广东省人民医院叶智明教授、暨南大学附属第一医院胡波教授、中山大学附属第八医院陈圳炜教授，广州市第一人民医院刘日光教授、深圳大学附属华南医院刘杨东教授、北京大学深圳医院梁伟教授担任联合主持人，集结广东省人民医院、中山大学附属第八医院、广州市第一人民医院、深圳大学附属华南医院四大中心联动开展。本次联播依托手术实操与学术分享，推广刻痕药球规范化应用，助力全国通路诊疗水平同质化提升。会议重点围绕刻痕药球在血透通路中的应用展开。刻痕药球通过在高压球囊表面集成定向刻痕件与抗增殖药物涂层，实现“定向切割+药物释放”的双重作用：一方面精准切割增生的内膜，改善解剖学狭窄；另一方面同步释放紫杉醇等药物，抑制平滑肌细胞过度增殖，显著降低再狭窄发生率。与会专家通过手术直播直观展示了刻痕药球处理复杂通路狭窄的标准化操作流程，并结合专题报告深入讨论了其相较于传统普通药物球囊在病变通过性、药物利用效率及远期通畅率等方面的优势。开场致辞本次会议分上、下午半场，分别由广东省人民医院叶智明教授、暨南大学附属第一医院胡波教授、中山大学附属第八医院陈圳炜教授，广州市第一人民医院刘日光教授、深圳大学附属华南医院刘杨东教授、北京大学深圳医院梁伟教授共同主持致辞。六位专家均表示，刻痕药物球囊兼具血管扩张与局部药物缓释双重作用，能够有效遏制血管内膜过度增生，针对内瘘狭窄、血管钙化、人工血管反复狭窄等复杂透析通路问题，具备良好的临床应用前景，有利于改善通路远期通畅率，减少多次重复手术干预。专家们同时谈到，本次多中心手术直播将完整展示刻痕球囊规范化操作步骤与实操要点，与会同道也将围绕血管通路疑难病例、标准化诊疗策略展开深度交流，分享前沿临床应用经验与个体化诊疗思路。广东省人民医院叶智明教授暨南大学附属第一医院胡波教授中山大学附属第八医院陈圳炜教授广州市第一人民医院刘日光教授深圳大学附属华南医院刘杨东教授北京大学深圳医院梁伟教授临床示范规范使用手术实操直播是本次会议的核心重磅环节，由广东省人民医院陶一鸣教授、中山大学附属第八医院陈圳炜教授，广州市第一人民医院陈浩雄、何汉昌教授、深圳大学附属华南医院刘杨东教授依次作为主刀开展实操演示，完整展示规范化介入手术全流程，重点示范刻痕药物球囊在各类血管通路病变中的标准化操作步骤与使用策略。病例一术者：广东省人民医院叶智明教授团队陶一鸣教授患者情况：75岁女性患者，慢性肾脏病5期，规律血液透析病变情况：距离吻合口约3cm处头静脉狭窄手术方案：静脉入路，刻痕药球扩张治疗术前超声评估刻痕药球扩张中术后评估手术TIPS：刻痕药球包装带有保护套，在球囊入鞘时，先不要取下保护套，将保护套抵在鞘口上，送球囊入鞘，待球囊进入鞘后，再去除保护套，这样可以保护药物涂层。病例二术者：中山大学附属第八医院陈圳炜教授患者情况：55岁女性，慢性肾脏病5期，高血压3级，既往接受过3次内瘘介入治疗病变情况：AVG吻合口狭窄、穿刺段狭窄手术方案：预扩张+刻痕球囊治疗术前超声评估，静脉吻合口最狭窄处直径1.6mm 刻痕药球扩张中刻痕药球扩张后手术TIPS：小于2mm的狭窄，先进行预扩张，减少出血、血管破裂等术中并发症的发生。病例三术者：广州市第一人民医院刘日光教授团队陈浩雄教授患者情况：72岁女性，尿毒症，高血压，透析两年半，既往进行过9次PTA治疗病变情况：人工动静脉瘘反复狭窄，内膜增生型病变手术方案：高压球囊预扩，再使用刻痕药球治疗术前超声评估，内膜增生严重刻痕药球扩张中扩张治疗后手术TIPS：刻痕药球自带刻痕件，扩张效果优于普通高压球囊。药物释放后，可以当成刻痕球囊再处理残余狭窄。病例四术者：广州市第一人民医院刘日光教授团队何汉昌教授患者情况：42岁女性，慢性肾病5期，维持性血液透析5年余，内瘘震颤减弱1个月，既往5次PTA治疗病变情况：人工动静脉内瘘狭窄，血流不足，小于180ml/min，最狭窄处1.1mm 手术方案：刻痕药物球囊治疗刻痕药球扩张中扩张后评估对残余狭窄进行二次扩张后评估手术TIPS：刻痕药球扩张时间120~180s，保证药物彻底转载完成。定向刻痕件聚焦压力，对高抵抗、钙化病变扩张强劲，扩张效果优于传统高压球囊。药物释放完成后，可将刻痕药球退至导管鞘中，若需要再次扩张，直接送至目标部位进行扩张，不建议多次入鞘。病例五术者：深圳大学附属华南医院刘杨东教授患者情况：54岁男性，慢性肾脏病5期，维持性透析7年余，既往PTA治疗3次病变情况：静脉穿刺区域狭窄，漂移段狭窄手术方案：顽固反复狭窄，使用6mm定向刻痕球囊预扩，获得充分管腔后用7mm刻痕药球治疗术前评估，内膜增生严重定向刻痕球囊预扩中刻痕球囊预扩后刻痕药球扩张中扩张完成后手术TIPS：定向刻痕球囊和刻痕药球的刻痕件采用镍钛绕簧技术，在保持足够的扩张能力的同时，过弯也非常顺畅，对于血透通路病变来说，这个设计非常实用。超过1.2mm的内膜对药物吸收效果会减弱，所以需要利用刻痕件均匀切割内膜，帮助药物更好渗透，抑制平滑肌细胞增生。循证加持疗效印证围绕血液透析血管通路介入领域现存诊疗痛点，本次大会特设多场专题学术分享环节。由广东省人民医院冯仲林教授、中山大学附属第八医院陈圳炜教授、广州市第一人民医院刘日光教授、深圳大学附属华南医院刘杨东教授四位专家依次带来深度授课，分别从中心静脉病变介入治疗模式、刻痕药球在不同病变的选择及应用、药物球囊在透析通路中的应用、刻痕药物球囊 RCT 研究进展与真实世界应用分享四大核心议题展开讲解。专家融合循证研究成果与一线真实手术案例，细致梳理各款介入球囊适配范围、标准化操作流程，多角度论证刻痕药球为透析患者通路带来的长期临床获益。中心静脉病变目前各大中心发生率非常高，随着介入器械的不断发展，中心静脉狭窄能选择的工具越来越多，介入治疗首选也是PTA。压力聚焦型球囊对于高压球囊优势明显，均匀规律撕裂内膜，明显减少并发症。切割球囊慎用，因为中心静脉若发生出血等并发症，处理起来难度较大。对于内膜增生型病变，药物球囊同样有效。专题分享：广东省人民医院关于中心静脉病变的介入治疗模式广东省人民医院冯仲林教授内膜增生是药物球囊作用的主要目标，狭窄也并不全是内膜增生导致，所以根据不同的病变选择合适的器械非常重要。刻痕药球是目前国内唯一一款适应症包含AVG病变的药球，今天的病例也是根据实际情况选择了最适合的刻痕药球。专题分享：刻痕药球在不同病变的选择及应用中山大学附属第八医院陈圳炜教授血透通路狭窄治疗中，PTA的局限性困扰临床已经，一期通畅率始终不高，再狭窄率高，但同时，可重复性也是PTA治疗的一个优势，但是对患者来说，压力很大。越来越多的临床研究证实,DCB的疗效显著优于普通高压球囊。目前国内获批的血透通路药球一共四款，刻痕药球是唯一一款集高压、刻痕、药涂于一体的药球，也是唯一一款包含AVF和AVG双适应症的药物球囊。刘教授表示，随着集采的落地，药球价格大幅降低，日后临床对器械的选择限制减少，对于合适的病例，药物球囊能活的更长的通畅时间。专题分享：药物球囊在透析通路中的应用广州市第一人民医院刘日光教授管腔准备对于药球疗效非常重要，国内外研究均指出，刻痕/切割球囊可以增强药球疗效，延长内瘘通畅时间。刘教授分享了定向刻痕+DCB的研究，结果显示，不论是初次狭窄还是反复狭窄，获益明显。刻痕药球刻痕件高度0.36mm，同时刻痕件上也有药物涂层，在充分扩开病变的同时，药物可以直达中膜层，抑制平滑肌细胞增生。临床试验数据也证实，在无预扩的情况下，6个月一期通畅率达到82.7%，无论是AVF还是AVG病变，刻痕药球在器械成功率、延长内瘘通畅时间等方面均取得优异的结果。专题分享：刻痕药物球囊 RCT 研究进展与真实世界应用分享深圳大学附属华南医院刘杨东教授总结「刻痕药球鼎级守护」第四期多中心手术联播圆满收官。本次活动充分展示了高压刻痕三合一药物球囊在复杂、难治性血透通路病变中的标准化应用方式，凸显其重要的临床价值与循证意义。产品融合定向刻痕、高压扩张、药物缓释三重机制，可有效应对血管钙化、瘢痕病变、顽固性复发性狭窄等疑难病变，抑制内膜增生、改善血管通畅性，助力提升透析通路远期通畅率、延长通路寿命，为终末期肾病患者透析通路保驾护航。直播回放链接及二维码网页端回放链接： https://meeting.talkmed.com/w/live/4040478630 回放二维码：（扫码即可进入回放）

2026-06-24

·药咖荟

北肿沈琳团队主导研发，全球首款CLDN 18.2 实体瘤CAR-T成功获批 | 科学顾问沈琳

沈琳CBIITA联合体科学顾问北京大学肿瘤医院原副院长北京市肿瘤防治研究所原副所长北京学者、北京市突出贡献专家 2026年6月22日，国家药品监督管理局经优先审评审批，正式批准恺兴生命科技（上海）有限公司自主研发的全球首创靶向Claudin18.2自体人源化CAR-T细胞治疗产品——舒瑞基奥仑赛注射液上市，用于治疗CLDN18.2阳性、HER2阴性，且经至少二线系统治疗失败的晚期胃癌/食管胃结合部腺癌。该产品可广泛覆盖Claudin18.2阳性实体瘤，对晚期胃癌、食管胃结合部腺癌及胰腺癌均具备治疗潜力，为晚期消化道肿瘤患者带来了全新治疗方案。此次上市批准基于确证性 II 期临床试验 CT041-ST-01（NCT04581473）的优异临床数据。该项研究由北京大学肿瘤医院沈琳教授牵头，联合全国 24 家临床中心共同完成，研究成果刊发于《柳叶刀》（The Lancet，DOI: 10.1016/S0140-6736 (25) 00860-8），并在 2025 年美国临床肿瘤学会（ASCO）年会作口头报告。临床数据证实，相较于研究者自选标准后线方案（纳武利尤单抗、紫杉醇、多西他赛、伊立替康、阿帕替尼等），舒瑞基奥仑赛可显著延长患者中位无进展生存期（mPFS：3.25 个月 vs 1.77 个月，HR=0.37，P<0.0001）。作为国内消化道肿瘤精准治疗领域的领军者，北大肿瘤医院沈琳教授团队针对 Claudin 18.2 靶点与实体瘤 CAR-T 细胞治疗的系统性攻关已持续多年，是全球最早开展 CLDN18.2 靶向 CAR-T 临床探索的研究团队之一。团队自 2019 年启动 CT041 I期临床研究，率先在晚期消化道肿瘤患者中验证靶向 CLDN18.2 自体 CAR-T 的安全性与抗肿瘤活性，2022 年和2024年两次在《Nature Medicine》发表I期数据，为实体瘤细胞治疗建立关键循证依据，且同步在 ASCO 年会做口头报告，也为后续 Ⅱ 期确证试验的落地奠定了扎实基础。除 CAR-T 赛道外，沈琳教授团队同步布局 CLDN18.2 全赛道创新，牵头多款靶向该靶点的单抗、ADC 药物国内外多中心临床，持续完善胃癌 CLDN18.2 精准诊疗体系，填补实体瘤细胞免疫治疗领域国内外研究空白。 /END/ < · 往期回顾 > △ 精彩回顾 | 2025第七届中国生物医药产业链创新转化论坛，亮点集锦 △ 精彩回顾 | 2024第六届中国生物医药产业链创新转化论坛，亮点集锦 △ 聚焦“国之大者”CBIITA 联合体荣获“中国产学研合作十大好平台” 更多优质内容，欢迎关注媒体合作投稿转载/资料领取/加入社群请添加药小咖与/智/者/同/行为/创/新/赋/能

2026-06-24

·fda

FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication, supported by ASCENT-04/KEYNOTE D-19, is for sacituzumab govitecan-hziy in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.Full prescribing information for Trodelvy, Keytruda, and Keytruda Qlex will be posted on Drugs@FDA.Efficacy and SafetyEfficacy of sacituzumab govitecan-hziy as a single agent for TNBC was evaluated in ASCENT-03 (NCT05382299), a multicenter, open-label, randomized trial that enrolled 558 patients with unresectable locally advanced or metastatic TNBC who had not received previous systemic therapy for advanced disease and who were not candidates for PD-1 or PD-L1 inhibitor therapy. Patients were randomized (1:1) to either sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle or nab-paclitaxel on Days 1, 8, and 15 of a 28-day cycle, paclitaxel on Days 1, 8, and 15 of a 28-day cycle, or gemcitabine and carboplatin AUC2 on Days 1 and 8 of a 21-day cycle (the TPC arm).The primary efficacy outcome measure was progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1. Additional efficacy outcome measures included overall survival (OS) and confirmed objective response rate (ORR). Median PFS was 9.7 months (95% CI: 8.1, 11.1) in the sacituzumab govitecan-hziy arm and 6.9 months (95% CI: 5.6, 8.2) in the TPC arm (Hazard ratio 0.62 [95% CI: 0.50, 0.77]; p-value <0.0001). Confirmed ORR was 50% (95% CI: 44, 56) and 47% (95% CI: 41, 53) in the respective arms. OS data were immature.Efficacy of sacituzumab govitecan-hziy in combination with pembrolizumab was evaluated in ASCENT-04/KEYNOTE-D19 (NCT05382286), a multicenter, open-label, randomized trial that enrolled 443 patients with locally advanced or metastatic TNBC who had not received previous systemic therapy for advanced disease and whose tumor express PD-L1 (CPS ≥ 10) according to the PD-L1 IHC 22C3 pharmDx assay. Patients were randomized (1:1) to receive either sacituzumab govitecan-hziy on Days 1 and Day 8 of a 21-day cycle in combination with pembrolizumab on Day 1 of a 21-day cycle or nab-paclitaxel on Days 1, 8 and 15 of a 28-day cycle, paclitaxel on Days 1, 8 and 15 of a 28-day cycle, or gemcitabine and carboplatin AUC2 on Days 1 and 8 of a 21-day cycle in combination with pembrolizumab on Day 1 of a 21-day cycle (the TPC plus pembrolizumab arm).The primary efficacy outcome measure was PFS by BICR per RECIST v1.1. Additional efficacy outcome measures included OS and ORR. Median PFS was 11.2 months (95% CI: 9.3, 16.7) in the sacituzumab govitecan-hziy arm and 7.8 months (95% CI: 7.3, 9.3) in the TPC plus pembrolizumab arm (Hazard ratio 0.65 [95% CI: 0.51, 0.84]; p-value 0.0009). Confirmed ORR was 61% (95% CI: 55, 68) and 55% (95% CI: 48, 62) in the respective arms. OS data were immature.The prescribing information of sacituzumab govitecan-hziy contains a boxed warning for diarrhea and neutropenia and includes warnings and precautions for hypersensitivity and infusion-related reactions, nausea/vomiting, patients with reduced UGT1A1 activity, and embryo-fetal toxicity.The prescribing information of pembrolizumab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.Recommended DosageThe recommended sacituzumab govitecan-hziy dose as a single agent or in combination with pembrolizumab is 10 mg/kg administered as an intravenous infusion on Days 1 and 8 of each 21-day cycle. Sacituzumab govitecan-hziy should be continued until disease progression or unacceptable toxicity. Refer to the prescribing information for the recommended dosing information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph.This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Israel’s Ministry of Health (ImoH), the Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), and Switzerland’s Swissmedic (SMC). The application reviews are ongoing at the other regulatory agencies.This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved these applications one month ahead of the FDA goal date.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.

临床结果上市批准加速审批ASCO会议

100 项与紫杉醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00491	紫杉醇	L01CD01	DB01229

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
晚期胃癌	中国	DAE HWA PHARM Co., Ltd.	2024-09-19
晚期胃癌	中国	上海海和药物研究开发股份有限公司	2024-09-19
转移性胰腺腺癌	欧盟	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	冰岛	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	列支敦士登	Accord Healthcare SL	2024-01-05
转移性胰腺腺癌	挪威	Accord Healthcare SL	2024-01-05
铂类耐药性原发性腹膜癌	欧盟	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	冰岛	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	列支敦士登	Inceptua SA	2018-11-20
铂类耐药性原发性腹膜癌	挪威	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	欧盟	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	冰岛	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性卵巢上皮癌	挪威	Inceptua SA	2018-11-20
铂敏感性输卵管癌	欧盟	Inceptua SA	2018-11-20
铂敏感性输卵管癌	冰岛	Inceptua SA	2018-11-20
铂敏感性输卵管癌	列支敦士登	Inceptua SA	2018-11-20
铂敏感性输卵管癌	挪威	Inceptua SA	2018-11-20
生殖细胞瘤	日本	Bristol Myers Squibb Co.	2013-02-21
生殖细胞瘤	日本	Clinigen KK	2013-02-21

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
胰腺癌	申请上市	欧盟	Accord Healthcare SL	2023-11-09
转移性胰腺癌	临床3期	中国	上海谊众药业股份有限公司	2025-01-21
高级别胶质瘤	临床3期	中国	浙江大学	2024-04-01
HEGF2阴性乳腺癌	临床3期	中国	上海谊众药业股份有限公司	2023-09-25
皮肤鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
下咽癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
转移性头颈部鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
下咽部鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
喉鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08
口腔鳞状细胞癌	临床3期	美国	ECOG-ACRIN Medical Research Foundation, Inc.	2023-06-08

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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


NCT04929392 (CTgov)	临床2期	食管腺癌 \| 胃食管交界处癌 \| 食管鳞状细胞癌 ... 更多	3	External Beam Radiation Therapy+Carboplatin+Paclitaxel+Pembrolizumab+Lenvatinib Mesylate	衊願廠築構選衊鏇鹹構 = 夢築鹹製廠壓夢積壓襯膚鏇餘夢積淵鏇構鬱願 (齋顧衊鬱醖壓夢鹽衊繭, 製艱網製淵鬱遞鑰鏇遞 ~ 壓醖顧膚憲築蓋糧顧願) 更多	-	2026-06-23
NCT06332092 (FID-007-003, ASCO2026)	临床2期	头颈部鳞状细胞癌	45	FID-007 75 mg/m2	鹹鹹廠鑰網鹽遞選鹽膚(構網構鏇衊網壓鑰選鏇) = 鬱壓膚積鏇獵鹽鑰鹽鑰窪願選顧襯衊艱鏇鏇糧 (衊觸夢遞網構遞願鏇範 ) 更多	积极	2026-05-29
				FID-007 125 mg/m2	鹹鹹廠鑰網鹽遞選鹽膚(構網構鏇衊網壓鑰選鏇) = 鏇襯繭鏇蓋膚艱選憲醖窪願選顧襯衊艱鏇鏇糧 (衊觸夢遞網構遞願鏇範 ) 更多
NCT07001748 (STOPGAP II, ASCO2026)	临床2/3期	胃神经内分泌肿瘤二线 microsatellite stable	148	Intraperitoneal paclitaxel + Systemic treatment	襯夢鑰遞膚艱夢廠遞願(簾鑰齋範築築鏇範遞構) = 鑰鑰鑰壓遞鹽衊繭齋築鬱繭衊顧壓憲膚糧夢築 (醖鹽壓鬱壓窪鹹鏇觸鏇 )	积极	2026-05-29
				Systemic treatment	鏇顧築蓋願選簾憲淵積(築繭壓選鏇壓醖蓋膚繭) = 範淵餘範網範積簾鏇夢獵繭襯顧艱鹹壓廠壓蓋 (淵襯積夢遞觸遞構鹽遞 ) 更多
K-TAIL-201 (ASCO2026)	临床2期	非鳞状非小细胞肺癌一线	32	Atezolizumab+Bevacizumab+Carboplatin+Paclitaxel	遞鹹淵願窪網襯構鹹構(窪築願壓觸壓簾糧鏇膚) = 鏇範醖簾築蓋艱窪網選築襯艱衊顧遞窪齋憲繭 (鹹鑰網鹹廠簾願繭廠鹹, 40.6 ~ 76.3) 更多	积极	2026-05-29
NCT04090398 (ETCTN 10302, ASCO2026)	临床2期	转移性乳腺癌 HER2-negative	70	Radium-223 dichloride + Paclitaxel	簾艱鹹願襯觸築構襯觸(餘衊窪遞構觸範膚製憲) = 醖選淵構觸艱鹽選艱鹽鏇餘艱範積壓網夢繭夢 (鑰齋鹹觸窪餘鏇願醖獵 ) 更多	不佳	2026-05-29
				Paclitaxel	簾艱鹹願襯觸築構襯觸(餘衊窪遞構觸範膚製憲) = 鏇鑰衊鹹選衊願壓顧選鏇餘艱範積壓網夢繭夢 (鑰齋鹹觸窪餘鏇願醖獵 ) 更多
ASCO2026	N/A	肛门鳞状细胞癌一线	54	Q3-week carboplatin-paclitaxel	鏇廠範憲膚襯膚簾獵遞(夢願餘窪築鏇築餘醖糧) = 餘蓋餘膚鑰選鏇蓋鑰築鬱夢製膚糧憲夢壓膚築 (鏇鹹製艱膚鏇鏇齋積壓, 15.7 ~ NR) 更多	积极	2026-05-29
				Standard (d1,8,15 Q28-day cycle) carboplatin-paclitaxel	鏇廠範憲膚襯膚簾獵遞(夢願餘窪築鏇築餘醖糧) = 構範構鑰憲膚遞顧膚願鬱夢製膚糧憲夢壓膚築 (鏇鹹製艱膚鏇鏇齋積壓, 11.2 ~ NR) 更多
NCT05185947 (CTgov)	临床2期	卵巢癌 \| 乳腺癌 \| 阑尾肿瘤 ... 更多	21	Nilotinib+Paclitaxel (Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1)	顧艱製顧蓋鹹簾簾網廠 = 艱鏇蓋襯網願壓顧鑰齋淵窪簾憲築獵範鑰淵廠 (積願獵積繭襯積築艱構, 範鹽餘憲膚蓋鬱獵廠齋 ~ 鹽築糧網壓餘艱鏇選襯) 更多	-	2026-05-29
				Nilotinib+Paclitaxel (Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1)	顧艱製顧蓋鹹簾簾網廠 = 繭顧鹽選鑰憲餘廠襯積淵窪簾憲築獵範鑰淵廠 (積願獵積繭襯積築艱構, 觸齋蓋淵廠窪糧製淵簾 ~ 顧遞築簾艱齋顧蓋淵衊) 更多
NCT05294900 (NEOS, CTgov)	临床2期	头颈部鳞状细胞癌	79	carboplatin+Paclitaxel	鏇蓋鏇獵鏇膚廠選鑰鹽 = 醖鹽鏇鬱顧顧積鑰製蓋糧淵襯遞願糧積餘觸願 (膚餘顧築鹹繭構顧窪齋, 襯憲膚糧製憲鑰觸製衊 ~ 範築壓憲襯範鬱襯糧積) 更多	-	2026-05-26
NCT04245085 (ETOP 15-19 ABC-lung \| ETOP ABC-lung \| ABC-lung, CTgov)	临床2期	EGFR突变的非小细胞肺癌	95	Carboplatin+Paclitaxel+Atezolizumab+Bevacizumab (Arm A)	艱鹹願鏇築衊鹹廠鬱築 = 餘網夢鹽窪構窪餘蓋簾窪醖壓顧鬱願衊鹹夢夢 (醖鬱製鹹繭簾鏇繭醖積, 壓糧廠鹽顧餘觸網製構 ~ 範築積願選顧鬱獵築衊) 更多	-	2026-05-12
				Atezolizumab+Bevacizumab+Pemetrexed (Arm B)	艱鹹願鏇築衊鹹廠鬱築 = 衊鑰襯糧選鏇廠壓遞襯窪醖壓顧鬱願衊鹹夢夢 (醖鬱製鹹繭簾鏇繭醖積, 積鬱醖鹹鏇鹹襯衊窪鹽 ~ 網遞鏇衊繭窪餘簾衊糧) 更多
NCT04339738 (Alliance A091902, CTgov)	临床2期	血管肉瘤 \| 软组织肉瘤	90	FDG-Positron Emission Tomography+Nivolumab+Paclitaxel (Arm I (Nivolumab, Paclitaxel))	蓋淵餘製簾糧獵憲窪廠(鑰構願窪鹹鹽鑰鹹範築) = 憲網顧簾範顧艱範衊選憲膚鬱觸簾膚獵憲網鏇 (襯壓蓋繭鑰選膚夢餘鑰, 簾憲獵衊積築鬱窪顧構 ~ 選願鑰膚餘窪夢壓製鹹) 更多	-	2026-05-05
				FDG-Positron Emission Tomography+Paclitaxel (Arm II (Paclitaxel))	蓋淵餘製簾糧獵憲窪廠(鑰構願窪鹹鹽鑰鹹範築) = 艱淵鑰艱願蓋齋憲觸蓋憲膚鬱觸簾膚獵憲網鏇 (襯壓蓋繭鑰選膚夢餘鑰, 夢醖窪衊網憲顧蓋齋憲 ~ 膚夢製壓鹹壓壓積衊構) 更多