An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone.
Participants will:
* Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
* Visit clinic at least every two weeks for checkups and tests
* Complete scans approximately every two months

开始日期2025-05-01

申办/合作机构

Delcath Systems, Inc.

NCT06245356

/ Not yet recruiting临床2期IIT

TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial

The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
The main questions it aims to answer are:
* Is this alternative chemotherapy option a better option in term of safety for this type of patients?
* Does the combination of treatments improves the overall safety?
* Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate?
* Does the combination of treatment have an effect on quality of life?
Participants will:
* Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with:
* Panitumumab or bevacizumab for colorectal adenocarcinomas
* Nivolumab or trastuzumab for gastroesophageal adenocarcinomas.
* Have a CT-Scan every 2 months until disease progression
* Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months
* Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis

开始日期2025-01-31

申办/合作机构

UNICANCER

[+1]

NCT06764680

/ Not yet recruiting临床2期IIT

Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With/without Involved Lesions Irradiation As 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial

The current phase 2, double cohort clinical trial was designed to determine the effectiveness of Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab with/without involved lesions irradiation as 3rd- or later-line therapy for advanced MSS/pMMR colorectal cancer.

开始日期2024-12-31

申办/合作机构

中山大学

100 项与曲氟尿苷替匹嘧啶相关的临床结果

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100 项与曲氟尿苷替匹嘧啶相关的转化医学

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100 项与曲氟尿苷替匹嘧啶相关的专利（医药）

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438

项与曲氟尿苷替匹嘧啶相关的文献（医药）

2024-12-14·BRITISH JOURNAL OF CANCER

Phase II Study of Irinotecan, Trifluridine/tipiracil (TAS-102) plus Bevacizumab as a Later-line Therapy for Patients with Metastatic Colorectal Cancer (mCRC): a prospective single-center explorative study

Article

作者: Yang, Wenwei ; Bi, Deying ; Yang, Tingting ; Liu, Na ; Li, Baoqi ; Sun, Yongkun ; Wu, Guifu

Abstract:

Purpose:

To explore the efficacy and safety of the combination of irinotecan, trifluridine/tipiracil (TAS-102), and bevacizumab in a later‐line setting for metastatic colorectal cancer (mCRC) patients.

Patients and methods:

This was a single-center, phase II trial. The mCRC patients who are refractory to standard first-line and second-line treatment are eligible. Patients who previously received irinotecan while progressing during maintenance therapy are also eligible. The primary endpoint was the objective response rate (ORR).

Results:

Between August 1, 2022, and September 30, 2023, 35 patients were enrolled, and 31 of them were evaluable for efficacy. The ORR was 25.8% (8/31), and the disease control rate (DCR) was 93.5% (29/31). As of April 30, 2024, the median progression-free survival (PFS) was 9.2 months (95% CI 6.285-12.115), whereas the median overall survival (OS) was not reached with the 1-year OS rate of 73.5%. The most common grade 3/4 treatment-related adverse events were neutropenia (34.3%), anemia (17.1%), and thrombocytopenia (8.6%).

Conclusion:

Irinotecan, TAS-102 plus bevacizumab regimen preliminarily demonstrated promising efficacy with tolerable toxicity for mCRC patients as later‐line treatment. This regimen warrants further exploration in refractory mCRC patients.

2024-12-06·ONCOLOGIST

Association between sidedness and survival among chemotherapy refractory metastatic colorectal cancer patients treated with trifluridine/tipiracil or regorafenib

Article

作者: Hsieh, Meng-Che ; Liu, Kuang-Wen ; Rau, Kun-Ming ; Hsiao, Kai-Yuan ; Chang, Wei-Shan ; Liang, Hao-Yun ; Chen, Hsin-Pao ; Shia, Ben-Chang

Abstract:

Background:

The impact of sidedness on survival of later-line treatment in patients with metastatic colorectal cancer (mCRC) is undetermined. This study aimed to investigate the association between sidedness and survival among chemotherapy refractory patients with mCRC treated with trifluridine/tipiracil (TAS-102) or regorafenib or both.

Patients and Methods:

Patients with mCRC treated with TAS-102 or regorafenib between 2015 and 2020 was retrospectively collected. Patients were stratified into TAS-102 first and regorafenib first, then subdivided into TAS-102 followed by regorafenib (T-R) and regorafenib followed by TAS-102 (R-T) groups. The oncologic outcomes were presented with time-to-treatment failure (TTF) and overall survival (OS).

Results:

After matching, 376 TAS-102 patients and 376 regorafenib patients were included for outcomes comparison. TTF had insignificant differences while OS was significantly different between TAS-102 and regorafenib groups. Median TTF and OS were 1.9 months versus 2.0 months (P = .701) and 9.1 months versus 7.0 months (P = .008) in TAS-102 and regorafenib, respectively. The OS benefits were consistent regardless primary tumor location. Subgroup analysis with 174 T-R patients and 174 R-T patients was investigated for treatment sequences. TTF and OS had significant differences in both groups. Median TTF and OS were 8.5 months versus 6.3 months (P = .001) and 14.4 months versus 12.6 months (P = .035) in T-R and R-T groups, respectively. The TTF and OS benefits were persisted regardless primary tumor location.

Conclusion:

TAS-102 first provided a better survival benefit in chemotherapy refractory patients with mCRC across all sidedness. Further prospective studies are warranted to validate our conclusions.

2024-12-01·Clinical Colorectal Cancer

Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial

Article

作者: Soler, Gemma ; Fakih, Marwan ; Taieb, Julien ; Roby, Lucas ; Ciardiello, Fortunato ; Prager, Gerald W ; Barboux, Valentine ; Amellal, Nadia ; Tabernero, Josep ; Van Cutsem, Eric ; Calleja, Elizabeth

BACKGROUND:

The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).

METHODS:

Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan-Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.

RESULTS:

Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.

CONCLUSION:

This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.

185

项与曲氟尿苷替匹嘧啶相关的新闻（医药）

2025-02-12

·信狐药迅

银诺医药1类新药依苏帕格鲁肽α获批上市用于治疗2型糖尿病获批上市| 新获批(1.20-2.9）

每周药品注册获批数据，分门别类呈现，一目了然。(1.20-2.9）新药上市申请药品名称企业注册分类受理号ASK120067片江苏奥赛康药业有限公司1CXHS2101052国;CXHS2101052IMP4297胶囊上海君派英实药业有限公司1CXHS2300074IMP4297胶囊上海君派英实药业有限公司1CXHS2300073左乙拉西坦缓释颗粒上海安必生制药技术有限公司2.2CXHS2300026巯嘌呤微片华润双鹤药业股份有限公司2.2CXHS2300091赛立奇单抗注射液重庆智翔金泰生物制药股份有限公司1CXSS2400001塔戈利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2400049苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300085苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300084苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300083苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300082苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300081苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300080苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300079苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300078司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400045 新药临床申请药品名称企业注册分类受理号JKN2306片健康元药业集团股份有限公司1CXHL2401175JKN2306片健康元药业集团股份有限公司1CXHL2401174CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401193CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401192NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401199NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401198SAR444656赛诺菲(中国)投资有限公司1CXHL2401212SAR444656赛诺菲(中国)投资有限公司1CXHL2401211ICP-248片北京诺诚健华医药科技有限公司1CXHL2401218QBT-006颗粒山东青佰欣达医药科技有限公司1CXHL2401214QBT-006颗粒山东青佰欣达医药科技有限公司1CXHL2401213UBT251注射液联邦生物科技(珠海横琴)有限公司1CXHL2401227BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401234BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401233BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401231HWH340片湖北生物医药产业技术研究院有限公司1CXHL2401241HWH340片湖北生物医药产业技术研究院有限公司1CXHL2401240ADC308片嘉兴安帝康生物科技有限公司1CXHL2401239HSK44459片海思科医药集团股份有限公司1CXHL2401244HSK44459片海思科医药集团股份有限公司1CXHL2401243BL0175注射液上海弼领生物技术有限公司1CXHL2401248TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401180TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401179注射用培泰菁绿南京诺源医疗器械有限公司1CXHL240118718F-NYM005注射液无锡诺宇医药科技有限公司1CXHL2401197NEP018片深圳海王医药科技研究院有限公司1CXHL2401235NBB-002中硼(厦门)生物医药有限公司1CXHL2401242SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401249SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401250SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401251SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401257SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401256SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401255BPI-452080片贝达药业股份有限公司1CXHL2401265BPI-452080片贝达药业股份有限公司1CXHL2401264BPI-452080片贝达药业股份有限公司1CXHL2401263HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401183HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401182HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401181注射用ZHB601江苏众红生物工程创药研究院有限公司1CXHL2401252注射用咔喏霉素牡丹江友搏药业有限责任公司1CXHL2401258TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401272TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401271HT-101注射液苏州星曜坤泽生物制药有限公司1CXHL2401270XH-S004片浙江星浩澎博医药有限公司1CXHL2401279XH-S004片浙江星浩澎博医药有限公司1CXHL2401278HPB-143片杭州多域生物技术有限公司1CXHL2401282HPB-143片杭州多域生物技术有限公司1CXHL2401281TYK-00540片浙江同源康医药股份有限公司1CXHL2401284TYK-00540片浙江同源康医药股份有限公司1CXHL2401283INV-6452片广东省创新药转化医学研究院有限公司1CXHL2401293INV-6452片广东省创新药转化医学研究院有限公司1CXHL2401292Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401304Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401303Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401302Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401301HS-10502片江苏豪森药业集团有限公司1CXHL2401300HS-10502片江苏豪森药业集团有限公司1CXHL2401299AL2846胶囊正大天晴药业集团股份有限公司1CXHL2401309QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401276QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401275AY-1001安域生物科技(杭州)有限公司2.1CXHL2401289AY-1001安域生物科技(杭州)有限公司2.1CXHL2401288HXHTT024湖南慧泽生物医药科技有限公司2.2CXHL2401203司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2401232司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2401230注射用BSY001北京北生研医药科技有限公司2.2CXHL2401422注射用硼[10B]法仑海南普利制药股份有限公司2.2CXHL2401266ZL2301广东众丽医药科技有限公司2.2CXHL2401260ZL2301广东众丽医药科技有限公司2.2CXHL2401259ZL2301广东众丽医药科技有限公司2.2CXHL2401280利拉鲁肽注射液浙江和泽医药科技股份有限公司2.2CXHL2401290葡萄糖缓释颗粒北京科信必成医药科技发展有限公司2.2;2.4CXHL2401236注射用紫杉醇聚合物胶束山东华铂凯盛生物科技有限公司2.2;2.4CXHL2401237胶原酶软膏远大生命科学(鞍山)有限公司2.4CXHL2401189注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2401253格索雷塞片上海正大天晴医药科技开发有限公司2.4CXHL2401254西达本胺片深圳微芯生物科技股份有限公司2.4CXHL2401285泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHL2401298泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHL2401297SYS6017(带状疱疹mRNA疫苗)石药集团巨石生物制药有限公司1.2CXSL2400778二价肠道病毒灭活疫苗(Vero细胞)北京民海生物科技有限公司1.4CXSL2400762四价肠道病毒灭活疫苗(Vero细胞)北京民海生物科技有限公司1.4CXSL2400761注射用聚乙二醇化促血小板生成肽重庆派金生物科技有限公司1CXSL2400770AK129注射液康方汇科(上海)生物有限公司1CXSL2400776注射用SKB445四川科伦博泰生物医药股份有限公司1CXSL2400780IBI3010信达生物制药(苏州)有限公司1CXSL2400758注射用SIBP-A19上海生物制品研究所有限责任公司1CXSL2400757注射用AMT-754普众发现医药科技(上海)有限公司1CXSL2400760重组人源化抗表皮生长因子受体单抗注射液上海津曼特生物科技有限公司1CXSL2400769HX044注射液翰思艾泰生物医药科技(武汉)股份有限公司1CXSL2400783注射用BGB-A3055广州百济神州生物制药有限公司1CXSL2400785HB0017注射液华博生物医药技术(上海)有限公司1CXSL2400749TAEST16001注射液香雪生命科学技术(广东)有限公司1CXSL2400766GenSci120注射液长春金赛药业有限责任公司1CXSL2400764HBM9378(SKB378)注射液和铂医药(上海)有限责任公司1CXSL2400771GC310腺相关病毒注射液北京锦篮基因科技有限公司1CXSL2400774GC310腺相关病毒注射液北京锦篮基因科技有限公司1CXSL2400775ICG318 CAR-T细胞注射液松鹤免疫生物医疗(深圳)有限公司1CXSL2400773GLS-W1100胶囊杭州远大生物制药有限公司1CXSL2400784AA001单抗北京智源鸿晟生物医药有限公司1CXSL2400788HT-102注射液苏州星曜坤泽生物制药有限公司1CXSL2400790BA1106注射液山东博安生物技术股份有限公司1CXSL2400796AWT020注射用无菌粉末上海君实生物医药科技股份有限公司1CXSL2400793注射用BL-M07D1成都百利多特生物药业有限责任公司1CXSL2400792SCT650C 注射液神州细胞工程有限公司1CXSL2400801CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400804GenSci120注射液长春金赛药业有限责任公司1CXSL2400803CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400802ESG206注射液上海诗健生物科技有限公司1CXSL2400807KYS202002A注射液江苏康缘药业股份有限公司1CXSL2400808注射用YL201苏州宜联生物医药有限公司1CXSL2400828恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2400782A140注射液四川科伦博泰生物医药股份有限公司2.2CXSL2400786LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400794LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400795夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400806夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400805注射用BAT1006百奥泰生物制药股份有限公司2.4CXSL2400798 仿制药申请药品名称企业注册分类受理号醋氯芬酸片江苏吉贝尔药业股份有限公司3CYHS2300707头孢丙烯干混悬剂国药集团致君(深圳)制药有限公司3CYHS2300773左氧氟沙星口服溶液安徽四环科宝制药有限公司3CYHS2301258氨氯地平贝那普利胶囊浙江高跖医药科技股份有限公司3CYHS2301300注射用比阿培南安徽省先锋制药有限公司3CYHS2301365米力农注射液浙江亚瑟医药有限公司3CYHS2301494米力农注射液浙江亚瑟医药有限公司3CYHS2301493尼麦角林片北京九能天远科技有限公司3CYHS2301585尼麦角林片海南斯达制药有限公司3CYHS2301664复合磷酸氢钾注射液石家庄四药有限公司3CYHS2301676依帕司他片江苏东科康德药业有限公司3CYHS2301765头孢羟氨苄片海南广升誉制药有限公司3CYHS2301830头孢羟氨苄片海南广升誉制药有限公司3CYHS2301829磷酸奥司他韦干混悬剂福建省宝诺医药研发有限公司3CYHS2301932磷酸奥司他韦颗粒成都第一制药有限公司3CYHS2301973奥沙西泮片湖南洞庭药业股份有限公司3CYHS2302048美索巴莫注射液华润双鹤利民药业(济南)有限公司3CYHS2302187磷酸奥司他韦干混悬剂广东红珊瑚药业有限公司3CYHS2302274葡萄糖酸钙注射液浙江沣华医药科技有限公司3CYHS2302296法莫替丁注射液云南药科院生物医药股份有限公司3CYHS2302358重酒石酸间羟胺注射液锦州奥鸿药业有限责任公司3CYHS2302395注射用盐酸罗沙替丁醋酸酯广东众生药业股份有限公司3CYHS2302623法莫替丁注射液成都归合科技有限公司3CYHS2302636普瑞巴林口崩片江西施美药业股份有限公司3CYHS2301762普瑞巴林口崩片江西施美药业股份有限公司3CYHS2301761复方氨基酸(16AA)/葡萄糖(12.6)电解质注射液福建盛迪医药有限公司3CYHS2301098氨溴特罗口服溶液山东京卫制药有限公司3CYHS2301056盐酸利多卡因注射液江苏长江药业有限公司3CYHS2302033盐酸多巴胺注射液山西惠达林曦医药科技有限公司3CYHS2301746生理氯化钠溶液北京柏雅联合药物研究所有限公司3CYHS2302042米诺地尔搽剂四川科伦药业股份有限公司3CYHS2300598米诺地尔搽剂四川科伦药业股份有限公司3CYHS2300597富马酸福莫特罗吸入溶液立生医药(苏州)有限公司3CYHS2202102国;CYHS2202102甲氨蝶呤片国药一心制药有限公司3CYHS2301363无水乙醇注射液北京同济达药业有限公司3CYHS2301982酮咯酸氨丁三醇注射液四川新斯顿制药股份有限公司3CYHS2201428奥美拉唑碳酸氢钠干混悬剂(I)山东益康药业股份有限公司3CYHS2300355马来酸曲美布汀片山西振东安欣生物制药有限公司3CYHS2300384阿立哌唑口腔崩解片北京星昊医药股份有限公司3CYHS2300395阿立哌唑口腔崩解片北京星昊医药股份有限公司3CYHS2300394西他沙星细粒济川药业集团有限公司3CYHS2300503布洛芬注射液西安汉丰药业有限责任公司3CYHS2300749盐酸去氧肾上腺素注射液海南普利制药股份有限公司3CYHS2300995盐酸去氧肾上腺素注射液海南普利制药股份有限公司3CYHS2300994咪达唑仑口服溶液福安药业集团湖北人民制药有限公司3CYHS2301040咪达唑仑口服溶液福安药业集团湖北人民制药有限公司3CYHS2301039普瑞巴林口服溶液温岭市创新生物医药科技股份有限公司3CYHS2301083复方醋酸钠林格注射液赤峰源生药业有限公司3CYHS2301149复方醋酸钠林格注射液赤峰源生药业有限公司3CYHS2301148普瑞巴林口服溶液哈尔滨市康隆药业有限责任公司3CYHS2301427琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301475琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301474琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301473布美他尼注射液成都苑东生物制药股份有限公司3CYHS2301586钠钾镁钙注射用浓溶液仁合益康汇泽药业河北有限公司3CYHS2301702尼莫地平口服溶液南京泽恒医药技术开发有限公司3CYHS2301838氯化钾口服溶液哈尔滨誉衡制药有限公司3CYHS2301861氯化钾口服溶液哈尔滨誉衡制药有限公司3CYHS2301860盐酸右美托咪定注射液江西赣南海欣药业股份有限公司3CYHS2301902盐酸右美托咪定注射液江西赣南海欣药业股份有限公司3CYHS2301901硫酸沙丁胺醇注射液浙江恒研医药科技有限公司3CYHS2302013硫酸沙丁胺醇注射液四川国瑞药业有限责任公司3CYHS2302079复方电解质醋酸钠葡萄糖注射液南京赛瑞谱顿制药有限公司3CYHS2302151复方电解质醋酸钠葡萄糖注射液南京赛瑞谱顿制药有限公司3CYHS2302150左乙拉西坦氯化钠注射液贵州阜康仁制药有限公司3CYHS2302205间苯三酚口崩片浙江沣华医药科技有限公司3CYHS2302302注射用阿莫西林钠四川制药制剂有限公司3CYHS2302414注射用阿莫西林钠四川制药制剂有限公司3CYHS2302413注射用阿莫西林钠四川制药制剂有限公司3CYHS2302412二羟丙茶碱注射液西藏诺泽生物医药有限公司3CYHS2302503吸入用盐酸丙卡特罗溶液浙江恒研医药科技有限公司3CYHS2302956吸入用盐酸丙卡特罗溶液浙江恒研医药科技有限公司3CYHS2302955巴氯芬口服溶液成都倍特得诺药业有限公司3CYHS2400124富马酸福莫特罗吸入溶液江苏长泰药业股份有限公司3CYHS2300852注射用尼可地尔康普药业股份有限公司3CYHS2302713注射用尼可地尔康普药业股份有限公司3CYHS2302711琥珀酸普芦卡必利片山东新时代药业有限公司4CYHS2300935曲氟尿苷替匹嘧啶片江苏奥赛康药业有限公司4CYHS2301190曲氟尿苷替匹嘧啶片江苏奥赛康药业有限公司4CYHS2301189甲磺酸艾立布林注射液江西青峰药业有限公司4CYHS2301225注射用艾司奥美拉唑钠海南葫芦娃药业集团股份有限公司4CYHS2302081注射用艾司奥美拉唑钠海南葫芦娃药业集团股份有限公司4CYHS2302080普瑞巴林胶囊浙江昂利康制药股份有限公司4CYHS2302143普瑞巴林胶囊浙江昂利康制药股份有限公司4CYHS2302142地夸磷索钠滴眼液山东绅联药业股份有限公司4CYHS2302284他克莫司软膏江西施美药业股份有限公司4CYHS2302322他克莫司软膏江西施美药业股份有限公司4CYHS2302321盐酸莫西沙星片山西德元堂药业有限公司4CYHS2302348氢溴酸伏硫西汀片石家庄龙泽制药股份有限公司4CYHS2302356依托考昔片通化东宝药业股份有限公司4CYHS2302354依托考昔片通化东宝药业股份有限公司4CYHS2302353依托考昔片通化东宝药业股份有限公司4CYHS2302352瑞巴派特片辰欣药业股份有限公司4CYHS2302392瑞格列奈片通化万通药业股份有限公司4CYHS2302442溴芬酸钠滴眼液浙江莎普爱思药业股份有限公司4CYHS2302454溴芬酸钠滴眼液浙江莎普爱思药业股份有限公司4CYHS2302453氢溴酸伏硫西汀片江苏恩华药业股份有限公司4CYHS2302448脂肪乳注射液(C14-24)合肥源丰顺医药科技有限公司4CYHS2302465脂肪乳注射液(C14-24)合肥源丰顺医药科技有限公司4CYHS2302464亚叶酸钙注射液四川汇宇制药股份有限公司4CYHS2302488氢溴酸伏硫西汀片中山万汉制药有限公司4CYHS2302486氢溴酸伏硫西汀片中山万汉制药有限公司4CYHS2302485聚甲酚磺醛溶液湖南明瑞制药股份有限公司4CYHS2302549地夸磷索钠滴眼液桂林华诺威基因药业股份有限公司4CYHS2302545普瑞巴林胶囊大桐制药(中国)有限责任公司4CYHS2302612普瑞巴林胶囊大桐制药(中国)有限责任公司4CYHS2302611注射用头孢他啶阿维巴坦钠正大天晴药业集团股份有限公司4CYHS2302631布洛芬缓释胶囊湖北亨迪药业股份有限公司4CYHS2302627注射用维库溴铵成都苑东生物制药股份有限公司4CYHS2302672马来酸非尼拉敏盐酸萘甲唑啉滴眼液广州大光制药有限公司4CYHS2302719西格列汀二甲双胍片(II)浙江永太药业有限公司4CYHS2302714西格列汀二甲双胍片(I)浙江永太药业有限公司4CYHS2302712妥布霉素滴眼液浙江视方极医药科技有限公司4CYHS2302705氢溴酸伏硫西汀片石家庄四药有限公司4CYHS2302754阿仑膦酸钠片浙江恒研医药科技有限公司4CYHS2302750依折麦布片山东鲁抗医药股份有限公司4CYHS2302775地夸磷索钠滴眼液湖南华纳大药厂股份有限公司4CYHS2302765地夸磷索钠滴眼液湖南华纳大药厂股份有限公司4CYHS2302764他氟前列素滴眼液沈阳兴齐眼药股份有限公司4CYHS2302829复方α-酮酸片温州海鹤药业有限公司4CYHS2303205羟苯磺酸钙胶囊广东华南药业集团有限公司4CYHS2303351地夸磷索钠滴眼液南京华兴医药科技有限公司4CYHS2303457氧河南众益气体有限公司4CYHS2401016乳果糖口服溶液安徽新世纪药业有限公司4CYHS2302658乳果糖口服溶液福元药业有限公司4CYHS2303541达格列净二甲双胍缓释片(III)北京福元医药股份有限公司4CYHS2302742达格列净二甲双胍缓释片(I)北京福元医药股份有限公司4CYHS2302741氧(液态)首钢股份公司迁安钢铁公司4CYHS2401002头孢地尼颗粒国药集团致君(深圳)制药有限公司4CYHS2300795洛索洛芬钠凝胶贴膏乐明药业(苏州)有限公司4CYHS2301270熊去氧胆酸胶囊常州制药厂有限公司4CYHS2301769瑞戈非尼片石药集团欧意药业有限公司4CYHS2302121注射用硼替佐米山西普德药业有限公司4CYHS2302212玻璃酸钠滴眼液龙吉川(宁夏)医药科技发展有限公司4CYHS2302374利丙双卡因乳膏四川科伦药业股份有限公司4CYHS2302432恩格列净片山东新华制药股份有限公司4CYHS2302760米拉贝隆缓释片乐泰药业有限公司4CYHS2302823他克莫司缓释胶囊湖南科伦制药有限公司4CYHS2303199他克莫司缓释胶囊湖南科伦制药有限公司4CYHS2303198奥美沙坦酯氨氯地平片北京百奥药业有限责任公司4CYHS2300179富马酸福莫特罗吸入溶液天津金耀药业有限公司4CYHS2302420硫酸氨基葡萄糖胶囊北京朗迪制药有限公司4CYHS2302662阿帕他胺片四川科伦药业股份有限公司4CYHS2303016多种油脂肪乳注射液(C6-24)成都国为生物医药有限公司4CYHS2301836培哚普利氨氯地平片(I)杭州和泽坤元药业有限公司4CYHS2404330孟鲁司特钠颗粒广州博济生物医药科技园有限公司4CYHS2400823艾考糊精腹膜透析液青岛瑞奈医疗科技有限公司4CYHS2401682吸入用布地奈德混悬液宁波美舒医药科技有限公司4CYHS2302707蛋白琥珀酸铁口服溶液北京民康百草医药科技有限公司4CYHS2201491氟维司群注射液南京健友生化制药股份有限公司4CYHS2201613复方电解质注射液杭州民生药业股份有限公司4CYHS2201884利丙双卡因乳膏德全药品(江苏)股份有限公司4CYHS2300115复方托吡卡胺滴眼液湖北远大天天明制药有限公司4CYHS2300392利丙双卡因乳膏苏州二叶制药有限公司4CYHS2300566聚乙二醇钠钾散浙江国镜药业有限公司4CYHS2300922盐酸环喷托酯滴眼液山东绅联药业股份有限公司4CYHS2301333替米沙坦氨氯地平片北京百奥药业有限责任公司4CYHS2301330盐酸乌拉地尔注射液山东泰盛药物研究有限公司4CYHS2301468非诺贝特酸胆碱缓释胶囊福建省宝诺医药研发有限公司4CYHS2301502非诺贝特酸胆碱缓释胶囊福建省宝诺医药研发有限公司4CYHS2301501洛索洛芬钠凝胶贴膏北京泰德制药股份有限公司4CYHS2301716恩格列净片甘李药业山东有限公司4CYHS2301895注射用硼替佐米吉斯美(武汉)制药有限公司4CYHS2301908他克莫司缓释胶囊辰欣药业股份有限公司4CYHS2301980他克莫司缓释胶囊辰欣药业股份有限公司4CYHS2301979妥洛特罗贴剂北京泰德制药股份有限公司4CYHS2301978西甲硅油乳剂北京北陆药业股份有限公司4CYHS2302027复方电解质注射液(II)温岭市创新生物医药科技股份有限公司4CYHS2302045复方电解质注射液(II)温岭市创新生物医药科技股份有限公司4CYHS2302044马来酸阿伐曲泊帕片山东凤凰制药股份有限公司4CYHS2302165氟比洛芬凝胶贴膏武汉法玛星制药有限公司4CYHS2302265头孢地尼颗粒广州江正医药科技有限公司4CYHS2302270甲氨蝶呤注射液湖南慧泽生物医药科技有限公司4CYHS2302316盐酸二甲双胍片赤峰维康生化制药有限公司4CYHS2302314聚乙二醇钠钾散圣嘉(滨海)生物医药科技有限公司4CYHS2302335盐酸阿莫罗芬搽剂武汉诺安药业有限公司4CYHS2302347注射用替加环素浙江亚太药业股份有限公司4CYHS2302384利托那韦片齐鲁制药(海南)有限公司4CYHS2302393孟鲁司特钠咀嚼片海南锦瑞制药有限公司4CYHS2302439多索茶碱注射液山东益健药业有限公司4CYHS2302524环孢素软胶囊齐鲁制药有限公司4CYHS2302506注射用培美曲塞二钠四川百利药业有限责任公司4CYHS2302563注射用亚胺培南西司他丁钠/氯化钠注射液湖南科伦制药有限公司4CYHS2302635米拉贝隆缓释片南京美瑞制药有限公司4CYHS2302679达格列净片河北智恒医药科技股份有限公司4CYHS2302695四烯甲萘醌软胶囊河南泰丰生物科技有限公司4CYHS2302690注射用醋酸卡泊芬净广州瑞尔医药科技有限公司4CYHS2302702枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302789枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302788枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302787盐酸乌拉地尔注射液杭州民生药业股份有限公司4CYHS2302820盐酸乌拉地尔注射液杭州民生药业股份有限公司4CYHS2302819依西美坦片重庆圣华曦药业股份有限公司4CYHS2302937环孢素软胶囊齐鲁制药有限公司4CYHS2302962利格列汀片山东朗诺制药有限公司4CYHS2303095替米沙坦氨氯地平片(II)山西德元堂药业有限公司4CYHS2303152甘油磷酸钠注射液华夏生生药业(北京)有限公司4CYHS2303336甘油磷酸钠注射液北京布霖生物科技有限公司4CYHS2303341注射用盐酸吉西他滨四川百利药业有限责任公司4CYHS2303364恩格列净片湖南汉森制药股份有限公司4CYHS2303427富马酸二甲酯肠溶胶囊宜昌人福药业有限责任公司4CYHS2303483酒石酸溴莫尼定滴眼液乐信乐美(海南)生物科技有限公司4CYHS2303524达格列净片江苏德源药业股份有限公司4CYHS2303509达格列净片江苏德源药业股份有限公司4CYHS2303508富马酸卢帕他定片山东华铂凯盛生物科技有限公司4CYHS2400932依折麦布阿托伐他汀钙片(II)江西施美药业股份有限公司4CYHS2302561奥美沙坦酯片浙江华海药业股份有限公司4CYHS2302996奥美沙坦酯片浙江华海药业股份有限公司4CYHS2302995罗沙司他胶囊江苏万邦生化医药集团有限责任公司4CYHS2301374罗沙司他胶囊江苏万邦生化医药集团有限责任公司4CYHS2301373依折麦布阿托伐他汀钙片(I)江西施美药业股份有限公司4CYHS2302562奥美沙坦酯氨氯地平片江苏联环药业股份有限公司4CYHS2303069西妥昔单抗注射液四川科伦博泰生物医药股份有限公司3.3CXSS2300075聚乙二醇化重组人粒细胞刺激因子注射液杭州九源基因工程股份有限公司3.4CXSS2300032 进口申请药品名称企业注册分类受理号八氟丙烷脂质微球注射液LANTHEUS MI CANADA INC5.1JXHS2400011艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400044艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400043地氯雷他定片Mylan Laboratories Limited5.2JYHS2300021特立氟胺片INTAS PHARMACEUTICALS LTD.5.2JYHS2300033瑞戈非尼片Dr. Reddy′s Laboratories Ltd.5.2JYHS2300051他达拉非片Hetero Labs Limited5.2JYHS2300069他达拉非片Hetero Labs Limited5.2JYHS2300068他达拉非片Hetero Labs Limited5.2JYHS2300067Baxdrostat片AstraZeneca AB1JXHL2400264Baxdrostat片AstraZeneca AB1JXHL2400263INCB057643片Incyte Corporation1JXHL2400269INCB057643片Incyte Corporation1JXHL2400268PF-07220060Pfizer Inc.1JXHL2400299PF-07220060Pfizer Inc.1JXHL2400298PF-07220060Pfizer Inc.1JXHL2400297Adagrasib 片Mirati Therapeutics, Inc.2.4JXHL2400270DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400278DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400277DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400276PF-07868489Pfizer Inc.1JXSL2400216注射用MK-2400Merck Sharp & Dohme LLC1JXSL2400222输注用无菌冻干粉Telisotuzumab VedotinAbbVie Inc.1JXSL2400226DS-1062aDaiichi Sankyo, Inc.1JXSL2400231PIT565Novartis Pharma AG1JXSL2400232VAY736注射液Novartis Pharma AG1JXSL2400223MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400225Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400228帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400221注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2400229Eflapegrastim注射液Hanmi Pharm. Co., Ltd.3.1JXSL2400230注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214坎地沙坦酯氢氯噻嗪片江西施美药业股份有限公司3CYHL2400220坎地沙坦酯氢氯噻嗪片江西施美药业股份有限公司3CYHL2400219达普司他片上海博志研新药物研究有限公司3CYHL2400222伏环孢素软胶囊杭州中美华东制药有限公司3CYHL2400223他替瑞林片江苏杜瑞制药有限公司3CYHL2400221复方硫酸钠片山东诚创蓝海医药科技有限公司3CYHL2400216复方硫酸钠片保定天浩制药有限公司3CYHL2400215盐酸环苯扎林缓释胶囊鲁南贝特制药有限公司3CYHL2400218盐酸环苯扎林缓释胶囊鲁南贝特制药有限公司3CYHL2400217格隆溴铵新斯的明注射液南京正科医药股份有限公司3CYHL2400227右美沙芬安非他酮缓释片四川科伦药业股份有限公司3CYHL2400228盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400231盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400230吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHL2400234布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400226布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400225布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400224冻干人用狂犬病疫苗(人二倍体细胞)艾美荣誉(宁波)生物制药有限公司3.3CXSL2400789人纤维蛋白原郑州莱士血液制品有限公司3.4CXSL2400800人纤维蛋白原郑州莱士血液制品有限公司3.4CXSL2400799 中药相关申请药品名称企业注册分类受理号辛芪通鼻片北京以岭药业有限公司1.1CXZS2300024一贯煎颗粒上海凯宝药业股份有限公司3.1CXZS2400014苓桂术甘颗粒上海凯宝药业股份有限公司3.1CXZS2400013HC009合剂北京厚成医药科技有限公司1.1CXZL2400074苓仙颗粒苏州玉森新药开发有限公司1.1CXZL2400077柴芩宁神颗粒山西省中医药研究院(山西省中医院)1.1CXZL2400078 注：橙色字体部分结论为不批准或收到通知件；

上市批准申请上市

2025-01-25

·Business Wire

Natera Announces Successful Readout of Randomized, Phase III CALGB (Alliance) / SWOG 80702 Clinical Trial in Colorectal Cancer

AUSTIN, Texas,--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced new data from the randomized, Phase III CALGB (Alliance) / SWOG 80702 study. The study will be presented today, Jan. 25, 2025 as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA. This first-of-its-kind study evaluated whether Signatera-positive patients benefit from an escalation in adjuvant treatment. In the trial, Signatera was used to evaluate the benefit of adding celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the management of stage III colorectal cancer (CRC). The pre-specified analysis included approximately 1,000 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX (+/-) celecoxib. Key findings included: Signatera-positivity after surgery was predictive of a disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared to placebo (HR 0.55, 95% CI 0.39-0.80; p=0.001) among Signatera-positive patients with a three-year DFS of 44.1% versus 26.6%. Similar results were seen for OS (HR 0.58, 95% CI 0.38-0.90; p=0.013). No survival benefit was seen by adding celecoxib to chemotherapy in Signatera-negative patients. Signatera status after surgery and prior to starting adjuvant therapy was highly predictive of recurrence. Signatera-positivity was significantly associated with worse DFS (HR 7.14, 95% CI: 5.54-9.21; p<0.0001) and OS (HR 6.72, 95% CI: 4.91-9.18; p<0.0001). “ The results from the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “ We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable, and well-tolerated therapy. These data also offer compelling evidence to address an unmet need in adjuvant colorectal cancer treatment, where there has not been a new drug approval in over 20 years.” The results of the randomized, double-blind ALTAIR clinical trial will also be presented in a poster today. ALTAIR examined treatment escalation with Trifluridine/Tipiracil (FTD/TPI) in patients with stage I-IV colorectal cancer. In the trial, 243 Signatera-positive patients were randomized to FTD/TPI or placebo over a six-month treatment period. The results showed a trend toward benefit in the FTD/TPI group (median DFS of 9.3 months vs. 5.6 months in the placebo group), although it did not reach statistical significance (HR, 0.79; P = 0.107). There was a significant benefit for resected oligometastatic stage IV patients treated with FTD/TPI, showing a median DFS of 9.76 months as compared to 3.96 months in the placebo group (HR, 0.53; P = 0.012). This presents an opportunity for clinical benefit in stage IV patients who test positive for MRD. About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .

临床结果临床3期ASCO会议免疫疗法

2025-01-25

·EndPoints

Agenus continues partnership talks for anti-CTLA-4 combo with new Phase 2 data

Five months after the FDA blocked its plans for accelerated approval, Agenus is moving ahead with discussions with potential pharma partners to chart a more conventional registrational path for its anti-CTLA-4 drug combo that has new Phase 2 data in advanced colorectal cancer. There are a variety of different partnership proposals on the table, with some focused on co-developing and others on financing, Agenus chief medical officer Steven O’Day told Endpoints News in an interview. “These negotiations are active — they’re moving forward,” he said. During its second-quarter earnings call last year, the company already indicated that it was looking for partnerships for botensilimab, which is combined with its PD-1 candidate balstilimab (BOT/BAL). According to data presented Saturday at the ASCO Gastrointestinal Cancers Symposium in San Francisco, the biotech’s 75 mg dose of botensilimab combined with balstilimab achieved a 19% objective response rate in patients with refractory microsatellite stable metastatic colorectal cancer that had spread to certain body parts but not the liver. This compares well with an ORR of zero for the control arm, which featured standard-of-care: Bayer’s Stivarga or Taiho Pharmaceutical’s Lonsurf. The 75 mg treatment cohort also achieved a 55% disease control rate. This means that more than half the patients treated with the combo were no longer progressing, O’Day said. Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? The company has regulatory “alignment” to move forward with the 75 mg regimen in a Phase 3 trial with survival as a primary endpoint, he added. In July 2024, the FDA advised Agenus against pursuing accelerated approval for BOT/BAL based on data from previous Phase 1 and 2 studies in relapsed or refractory non-microsatellite instability-high colorectal cancer. The agency said that response rates in this population have not always translated to survival outcomes, adding it wanted to see a definitive survival study. Now that a Phase 3 is in the cards, Agenus has several options as to the specific subset of colorectal cancer patients it advances in, O’Day said. Other than the late-line setting, “we can also move into earlier-line metastatic colon and neoadjuvant” disease, he said. The company shared results from various BOT/BAL-based regimens in these other settings at ASCO GI. “But clearly the Phase 3 refractory [setting] is the most set up in terms of the work that’s been done with dose and contribution and a large database,” O’Day said. Agenus is no stranger to regulatory struggles. In 2021, the drugmaker withdrew its accelerated BLA for balstilimab in second-line cervical cancer shortly after the FDA cleared Merck’s Keytruda for full approval in the same setting. In August 2024, Bristol Myers Squibb turned its back on a pact with Agenus for a bispecific anti-TIGIT drug that featured more than $1 billion in potential milestones. Last month, the biotech launched a biologics manufacturing business to help it make money. In November, it had just $44.8 million in consolidated cash.

临床3期临床结果加速审批临床2期临床1期

100 项与曲氟尿苷替匹嘧啶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	曲氟尿苷替匹嘧啶	L01BC	DB08937

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
HER2阳性胃癌	韩国	Jeil Pharmaceutical Co., Ltd.	2019-10-17
转移性胃癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2017-05-23
转移性胃食管结合部腺癌	澳大利亚	SERVIER LABORATORIES (AUST.) PTY. LTD.	2017-05-23
胃食管交界处腺癌	欧盟	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	冰岛	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	列支敦士登	Les Laboratoires Servier SAS	2016-04-25
胃食管交界处腺癌	挪威	Les Laboratoires Servier SAS	2016-04-25
转移性结直肠癌	美国	Taiho Oncology, Inc.	2015-09-22
结直肠癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-03-24
胃癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-03-24

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
RAS/BRAF基因野生型结直肠癌	临床3期	美国	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	日本	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	比利时	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	丹麦	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	芬兰	Adir SRL	2022-04-21
RAS/BRAF基因野生型结直肠癌	临床3期	匈牙利	Adir SRL	2022-04-21
实体瘤	临床3期	法国	Servier Group	2022-01-30
大肠腺癌	临床2期	法国	Les Laboratoires Servier SAS	2025-01-31
双氢嘧啶脱氢酶缺乏	临床2期	法国	Les Laboratoires Servier SAS	2025-01-31
胃食管交界处癌	临床2期	法国	Les Laboratoires Servier SAS	2025-01-31

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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


ASCO_GI2025 人工标引	N/A	转移性结直肠癌	639	trifluridine-tipiracil	壓壓選鹽顧範積鏇鏇積(構簾壓獵鏇範鏇簾鹽膚) = 獵窪築範憲窪蓋糧蓋獵襯網遞憲觸鏇願選夢餘 (壓糧簾遞網餘願觸製蓋, 5.7 ~ 6.9) 更多	积极	2025-01-23
				trifluridine-tipiracil+bevacizumab	壓壓選鹽顧範積鏇鏇積(構簾壓獵鏇範鏇簾鹽膚) = 鬱夢築廠製選餘網顧醖襯網遞憲觸鏇願選夢餘 (壓糧簾遞網餘願觸製蓋, 7.8 ~ 16.0) 更多
ASCO_GI2025 人工标引	N/A	转移性结直肠癌	3,680	trifluridine-tipiracil	選鏇夢範齋艱網遞製網(範衊鏇齋鏇壓膚顧壓淵) = 鹽簾襯鑰願醖獵願醖餘襯遞窪鹽築範壓壓獵醖 (淵廠願觸構鏇蓋願構構, 6.1 ~ 6.6) 更多	积极	2025-01-23
				trifluridine-tipiracil+bevacizumab	選鏇夢範齋艱網遞製網(範衊鏇齋鏇壓膚顧壓淵) = 窪鹹鹹選夢鹹簾簾觸鹽襯遞窪鹽築範壓壓獵醖 (淵廠願觸構鏇蓋願構構, 8.0 ~ 10.1) 更多
NCT04457297 (ALTAIR, ASCO_GI2025) 人工标引	临床3期	结直肠癌	243	Trifluridine/Tipiracil (FTD/TPI)	簾壓窪壓鹹壓構繭窪襯(構廠醖繭選遞築鹽築窪) = 膚糧襯壓醖蓋繭淵網醖糧窪獵選糧範選網糧網 (鑰鹹獵鏇壓齋獵鹽憲醖 ) 未达到更多	不佳	2025-01-23
				Placebo	簾壓窪壓鹹壓構繭窪襯(構廠醖繭選遞築鹽築窪) = 鏇範衊選艱壓憲艱廠壓糧窪獵選糧範選網糧網 (鑰鹹獵鏇壓齋獵鹽憲醖 ) 未达到更多
ChiCTR2300078241 (ASCO_GI2025)	临床2期	转移性结直肠癌三线 RAS mutations	26	Fruquintinib	獵鑰壓鹽鑰築願艱鹽網(築膚壓鹽窪鑰鏇選醖鹽) = 醖膚廠餘觸壓觸齋鑰遞網願網淵淵憲積鹽構範 (積繭網鹹鬱壓衊鏇衊齋 ) 更多	积极	2025-01-23
				TAS-102	獵鑰壓鹽鑰築願艱鹽網(築膚壓鹽窪鑰鏇選醖鹽) = 餘淵餘範鬱憲憲餘製選網願網淵淵憲積鹽構範 (積繭網鹹鬱壓衊鏇衊齋 ) 更多
ASCO_GI2025	N/A	结直肠癌三线	75	TAS-102	壓壓遞蓋艱衊衊餘鬱鏇(鏇艱憲積蓋廠鬱襯築淵) = 願獵餘廠襯鹹選範糧網窪壓餘襯壓蓋獵築夢繭 (廠襯衊鹹構襯構遞鏇願 )	不佳	2025-01-23
				Chemotherapy rechallenge	壓壓遞蓋艱衊衊餘鬱鏇(鏇艱憲積蓋廠鬱襯築淵) = 鬱齋鹽構網構製繭鑰獵窪壓餘襯壓蓋獵築夢繭 (廠襯衊鹹構襯構遞鏇願 )
HGCSG2302 (ASCO_GI2025)	N/A	晚期胃癌	164	FTD/TPI plus Ramucirumab	簾壓壓壓鬱艱製夢構鏇(鑰獵顧鏇鏇遞構鏇願選) = 48.6% vs 52.4% (p=0.707) 憲製製廠壓夢齋簾鏇築 (蓋選壓憲糧構積範衊構 ) 更多	积极	2025-01-23
				FTD/TPI
NCT06202001 (ASCO_GI2025)	临床2期	转移性结直肠癌二线	60	Trifluridine/tipiracil (TAS-102) + Irinotecan + Bevacizumab	願網廠顧積遞憲糧繭鹹(積膚淵艱遞鹽淵獵齋顧) = 願壓鹽夢選鑰糧鬱遞壓鬱構獵鏇齋積醖鑰構窪 (憲鹽繭鏇淵艱醖襯窪齋 ) 更多	积极	2025-01-23
NCT02848079 (ASCO_GI2025)	临床1/2期	结直肠癌 RAS mutated	54	TAS102 with oxaliplatin (TASOX)	壓衊窪範鹹鏇鹽艱襯憲(構鏇壓憲繭鹹鬱膚鹹遞) = 壓鬱齋廠簾繭糧網鹽獵壓壓範遞廠鹽憲觸獵鑰 (構艱醖鹽醖構淵鑰餘積 ) 更多	积极	2025-01-23
ASCO_GI2025	N/A	MSI-high \| deficient MMR	18	trifluridine/tipiracil (FTD/TPI + BEV)	構餘鏇壓築醖醖夢積鹽(膚選選鏇繭窪選製遞夢) = 選襯鬱鹽壓襯襯鏇構選製醖蓋積鏇構鏇膚鹽廠 (選遞糧願觸衊窪構鏇鑰, 3.6 ~ 41.4) 更多	积极	2025-01-23
				trifluridine/tipiracil (FTD/TPI)	選餘繭製壓構艱壓顧鬱(構獵窪膚夢艱選鹹鑰構) = 憲艱鹽廠顧網遞糧蓋膚繭膚糧膚網餘製醖憲壓 (範遞壓廠餘積構齋鬱廠 )
BeTAS trial (ASCO_GI2025)	N/A	转移性结直肠癌三线 RAS mutations	208	Trifluridine/tipiracil and bevacizumab (FTD/TPI+BEV)	膚範積鏇積鹹鹽簾襯鬱(繭襯築糧選構鏇憲築觸) = 構鏇鏇簾鹹廠觸襯網襯壓鏇繭壓糧鹽範夢願醖 (網襯窪蓋窪糧鹽艱餘鏇 ) 更多	积极	2025-01-23