磷酸氟达拉滨(Fludarabine Phosphate) - 药物靶点：DNA polymerase III x RNA polymerase II x RNR_在研适应症：多发性骨髓瘤，骨髓增生异常综合征，费城染色体阳性慢性粒细胞白血病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

2-Fluoro-ara-AMP、2-Fluoroadenine-arabinoside、Beneflur

+ [17]

靶点

DNA polymerase III x RNA polymerase II x RNR

作用机制

DNA聚合酶III抑制剂、RNA聚合酶Ⅱ抑制剂、RNR抑制剂(核糖核苷酸还原酶复合体抑制剂)

治疗领域

肿瘤免疫系统疾病心血管疾病+ [4]

在研适应症

多发性骨髓瘤骨髓增生异常综合征费城染色体阳性慢性粒细胞白血病+ [24]

非在研适应症

急性红细胞白血病急性巨核细胞白血病伴有 11q23 异常的急性髓系白血病+ [118]

原研机构

Southern Research Institute

在研机构

Genzyme Corp.

National Cancer InstituteSanofi KK

+ [5]

非在研机构

Hoffmann-La Roche, Inc.

Novartis Pharmaceuticals Corp.

Sanofi-Aventis U.S. LLC

+ [9]

最高研发阶段批准上市

首次获批日期

美国 (1991-04-18),

慢性淋巴细胞白血病

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 (日本)、孤儿药 (韩国)、孤儿药 (美国)

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结构

分子式C10H13FN5O7P

InChIKeyGIUYCYHIANZCFB-FJFJXFQQSA-N

CAS号75607-67-9

关联

1,533

项与磷酸氟达拉滨相关的临床试验

NCT05521087 / Withdrawn临床1期

A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

开始日期2025-12-26

申办/合作机构

Janssen Research & Development LLC

NCT06698744 / Not yet recruiting临床1期IIT

A Phase 1 Single Arm, Open Label Study to Evaluate the Safety of UF-KURE-BCMA CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma

The purpose of this study is to determine if UF-KURE-BCMA (B-Cell Maturation Antigen) chimeric antigen receptor T cells (CAR-T cells) can be used to treat relapsed or treatment refractory multiple myeloma (RRMM). This treatment uses T cells already present within the body that have been modified outside of the body by a virus and then returned by an infusion to fight cancer. The investigators are evaluating UF-KURE-BCMA because it uses a manufacturing process that is shorter than other Food and Drug Administration (FDA) approved CAR-T cells and only requires a simple blood draw. The standard treatments require weeks to manufacture the cells as well a special procedure to get an individual's cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated. The use of UF-KURE-BMCA is investigational and is not approved by the FDA outside of clinical trials. This is the first study of UF-KURE-BCMA in patients.
Participants will give a pint of blood, which is the amount one would provide if they were to donate blood. The blood will be used to make the UF-KURE-BCMA cells. Participants will then receive chemotherapy followed by a one-time infusion of the experimental modified CAR-T cells. After this infusion, participants will be watched for side effects and follow up will continue for up to 15 years.

开始日期2025-04-25

申办/合作机构

The Case Comprehensive Cancer Center

NCT06660420 / Not yet recruiting临床1期IIT

Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)

To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.

开始日期2025-04-16

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与磷酸氟达拉滨相关的临床结果

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100 项与磷酸氟达拉滨相关的转化医学

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100 项与磷酸氟达拉滨相关的专利（医药）

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7,723

项与磷酸氟达拉滨相关的文献（医药）

2024-12-31·Journal of medical economics

A cost-consequence analysis of the Xpert Xpress CoV-2/Flu/RSV plus test strategy for the diagnosis of influenza-like illnesses

Article

作者: Miller, Cynthia ; Beaubrun, Anne ; Jensen, Ivar ; Boller, Emily ; Davies, Shawn ; Chase, Jordan

AIMS:

Influenza-like illnesses (ILI) affect millions each year in the United States (US). Determining definitively the cause of symptoms is important for patient management. Xpert Xpress CoV-2/Flu/RSV plus (Xpert Xpress) is a rapid, point-of-care (POC), multiplex real-time polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV). The objective of our analysis was to develop a cost-consequence model (CCM) demonstrating the clinico-economic impacts of implementing PCR testing with Xpert Xpress compared to current testing strategies.

METHODS:

A decision tree model, with a 1-year time horizon, was used to compare testing with Xpert Xpress alone to antigen POC testing and send-out PCR strategies in the US outpatient setting from a payer perspective. A hypothetical cohort of 1,000,000 members was modeled, a portion of whom develop symptomatic ILIs and present to an outpatient care facility. Our main outcome measure is cost per correct treatment course.

RESULTS:

The total cost per correct treatment course was $1,131 for the Xpert Xpress strategy compared with a range of $3,560 to $5,449 in comparators. POC antigen testing strategies cost more, on average, than PCR strategies.

LIMITATIONS:

Simplifying model assumptions were used to allow for modeling ease. In clinical practice, treatment options, costs, and diagnostic test sensitivity and specificity may differ from what is included in the model. Additionally, the most recent incidence and prevalence data was used within the model, which is not reflective of historical averages due to the SARS-CoV-2 pandemic.

CONCLUSION:

The Xpert Xpress CoV-2/Flu/RSV plus test allows for rapid and accurate diagnostic results, leading to reductions in testing costs and downstream healthcare resource utilization compared to other testing strategies. Compared to POC antigen testing strategies, PCR strategies were more efficient due to improved diagnostic accuracy and reduced use of confirmatory testing.

2024-12-31·Hematology

A network meta-analysis of the effectiveness of different basic preconditioning regiments in allogeneic hematopoietic stem cell transplantation

Article

作者: Zhang, Cai-Yun ; Wang, Chun-Li ; Wu, Si-Ting ; Wang, Li

OBJECTIVE:

To investigate and compare the effects of basic preconditioning regimens Bu/Cy, Cy/TBI and Flu/Bu for the treatment of patients in allogeneic hematopoietic stem cell transplantation.

METHODS:

It comprised exploring the published literature in the databases of PubMed, EMBASE, Cochrane Library, and Web of Science, using suitable keywords pertaining to various basic pretreatments Bu/Cy, Cy/TBI, and Flu/Bu, prior to allogeneic hematopoietic stem cell transplantation, and then extracting the searched outcome indicators of Overall Survival (OS) and survival (herein represented as OS and survival). Further, the results were estimated with meta-analysis using R, where the incidence of GVHD was reported in odds ratio (OR) with its 95% confidence interval (95%CI).

RESULTS AND DISCUSSION:

A total of 14 papers were included in this study, including 1436 cases were treated with Bu/Cy, 1816 cases with Cy/TBI, and 549 cases with Flu/Bu in the preconditioning regimen. After OS was the outcome pooled, compared with Flu/Bu in the preconditioning group, the results (Cy/TBI HR = 1.12 (95% Cl:1.04,1.61), Bu/Cy HR = 1.24 (95% Cl. 1.13,2.06)) showed that Flu/Bu preconditioning regimen significantly improved the overall survival rate of allogeneic HSCT patients. With the incidence of GVHD as the outcome summary, compared with Flu/Bu in the pretreatment group, the results (Cy/TBI HR = 1.24 (95% Cl:1.12, 1.82), Bu/Cy HR = 1.14 (95% Cl. 1.03, 2.12)) indicated that Flu/Bu in the pretreatment regimen group also significantly reduced the incidence of GVHD after allogeneic HSCT.

CONCLUSION:

Patients who received the basal preconditioning regimen Flu/Bu before allogeneic hematopoietic stem cell transplantation had the lowest hazard ratio for overall survival (OS) development. This indicates that the use of the basal preconditioning regimen Flu/Bu for the treatment of patients was the most effective, although the quality of the studies included needs to be confirmed by high-quality randomized controlled trials.

2024-12-31·Hematology (Amsterdam, Netherlands)

Lesson learned in pediatric haploidentical transplantation in a low-resource environment: delivering melphalan IV and using low dose radiation reduce graft failure

Article

作者: Gómez-De León, Andrés ; Jiménez-Antolinez, Valentine ; González-Lopez, Elias ; González-Llano, Oscar ; Gómez-Almaguer, David ; Colunga-Pedraza, Julia

Objectives: Primary graft failure (pGF) after hematopoietic stem-cell transplant is associated with considerable morbidity and mortality. The incidence in haplo-HSCT has been reported to be between 0% and 30%. In 2018, we identified a pGF incidence of 35% in our pediatric haplo-HSCT recipients with hematologic malignancies, which motivated us to enact changes to the conditioning regimen.Methods: We performed a single-center prospective, pre-post study of consecutive patients under 16 years with hematologic malignancies, from January 2015 to December 2022 who received a haplo-HSCT. Twenty-six pediatric patients received a haplo-HSCT before September 2018 (G1) and 36 patients after (G2). The main conditioning regimen for G1 was myeloablative with Flu/Cy/Bu, and for G2 the main regimen was reduced intensity Flu/Cy/Mel/TBI2.Results: Nine patients (35%) in G1 had primary graft failure, while in G2 there were no patients with pGF. The median follow-up for G1 was 15.9 months, and for G2 was 24.8 months, with an estimated overall survival at 12 months of 63% (95% CI 47-76) versus 85% (95% CI 73-93), and at 24 months of 47% (95% CI 31-64) versus 70% (95% CI 54-82) respectively (p = .007).Conclusion: After September 2018 conditioning regimen modifications were implemented with the objective of reducing primary failure, consisting mainly of switching from busulfan to melphalan as the alkylating agent of choice, and adding, when clinically possible TBI. Primary failure has been significantly reduced in our institution since then.

403

项与磷酸氟达拉滨相关的新闻（医药）

15 小时之前

·Business Wire

City of Hope Reveals New Data on Cancer Immunotherapies, Microbiome and Other Innovative Topics at 2024 American Society of Hematology (ASH) Annual Meeting

LOS ANGELES--( BUSINESS WIRE )-- City of Hope ® , one of the largest and most advanced cancer research and treatment organizations in the United States and ranked among the nation’s top 5 cancer centers by U.S. News & World Report, announced today that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH annual meeting from Dec. 7 to 10 in San Diego. City of Hope in ASH Press Program Two City of Hope researchers will present at ASH press briefings , and one of its leaders is a senior author on an abstract that will be discussed in the press program as well. Title: Increased Fiber Intake Results in Better Overall Survival and Lower GI-aGVHD in Allo-HCT Recipients and Pre-Clinical Gvhd Models Oral Abstract Number: 259 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST Presenter: Jenny Paredes , Ph.D., City of Hope staff scientist, who will also receive an ASH Outstanding Abstract Achievement Award for this research Title : A High-Fiber Dietary Intervention (NUTRIVENTION) in Precursor Plasma Cell Disorders Improves Biomarkers of Disease and May Delay Progression to Myeloma Oral Abstract Number: 671 Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST City of Hope Senior Author: Marcel van den Brink , M.D., Ph.D., president, City of Hope Los Angeles/City of Hope National Medical Center and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D. Title: Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of Epcore CLL-1 Oral Abstract Number: 883 Press Briefing Date/Time and Embargo Lift Time: Sunday, Dec. 8, 8 a.m. PST Presenter: Alexey Danilov , M.D., Ph.D., City of Hope Marianne and Gerhard Pinkus Professor in Early Clinical Therapeutics, and associate director, Toni Stephenson Lymphoma Center City of Hope ASH Oral Presentations In addition, City of Hope doctors will present 22 oral abstracts with the following highlights: Title: 980 Results From the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients With Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization Session Date and Time: Monday, Dec. 9, 4:45 p.m. PST Presenter: Jasmine Zain , M.D., City of Hope professor, Division of Lymphoma, and director, T Cell Lymphoma Program Title: 468 Randomized Phase 2 Trial of the Anti-PD-L1 Monoclonal Antibody Durvalumab Plus Lenalidomide Versus Single-Agent Durvalumab in Patients With Refractory/Advanced Cutaneous T Cell Lymphoma Session Date and Time: Sunday, Dec. 8, 10:45 a.m. PST Presenter: Christiane Querfeld , M.D., Ph.D., City of Hope professor, Division of Dermatology, and director, Cutaneous Lymphoma Program Title: 211 Updated Results and Longer Follow-Up From the AUGMENT-101 Phase 2 Study of Revumenib in All Patients With Relapsed or Refractory (R/R) KMT2Ar Acute Leukemia Session Date and Time: Saturday, Dec. 7, 2 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 524 Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients With Relapsed Refractory Transformed Indolent Lymphoma Session Date and Time: Sunday, Dec. 8, 9:45 a.m. Presenter: Swetha Kambhampati Thiruvengadam , M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation Title: 210 Disrupting Mitochondrial Dynamics and Metabolism in Leukemic Stem Cells through Mitochondrial PCNA Inhibition: The Role of AOH1996 Session Date and Time: Saturday, Dec. 7, 3:15 p.m. PST Presenter: Hyunjun Kang, Ph.D., City of Hope staff scientist, Department of Hematologic Malignancies Translational Science Title: 1043 Final Analysis of Phase 2a Study of Adding Itacitinib to Tacrolimus/Sirolimus Gvhd Prophylaxis After Fludarabine/Melphalan-Based Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, Myelodysplastic Syndrome (MDS), or Myelofibrosis (MF) Session Date and Time: Monday, Dec. 9, 5:30 p.m. PST Presenter: Haris Ali , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and section leader, Myeloproliferative Neoplasms Program Title: 966 CD19-CAR T Cells As Definitive Consolidation for Older Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study Session Date and Time: Monday, Dec. 9, 5:45 p.m. PST Presenter: Ibrahim Aldoss , M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title: 685 The Composite Health Risk Assessment Model (CHARM) Predicts Risks of Toxicities, Functional and Cognitive Decline Among Survivors of Allogeneic Hematopoietic Cell Transplantation (allo-HCT): A Prospective BMT-CTN Study 1704 Session Date and Time: Sunday, Dec. 8, 4:30 p.m. PST Senior Author: Andrew Artz , M.D., M.S., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and director, Aging and Blood Cancers Program City of Hope doctors will also lead in the following ASH events: The 13th Annual BMT & Cell Therapy Winter Workshop , co-chaired by Dr. Van den Brink, will be held on Friday, Dec. 6, 2024, prior to the ASH conference. The workshop focuses on innovative research pertinent to hematopoietic stem cell transplantation and cell therapy. Dr. Van den Brink will also speak at a scientific symposium titled “Placing the Brakes on Accelerated Aging” about targeting rejuvenation therapies to decelerate aging on Monday, Dec. 9, 2024. Jianjun Chen , Ph.D., Simms/Mann Family Foundation Chair in Systems Biology, will speak at a scientific workshop titled “Therapy Resistance Mechanisms in Blood Malignancies Program” about RNA modification and therapy resistance in acute leukemia on Friday, Dec. 6, 2024. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™ . For more information about City of Hope, follow us on Facebook , X , YouTube , Instagram and LinkedIn .

临床2期临床结果免疫疗法ASH会议细胞疗法

18 小时之前

·佰傲谷BioValley

狼疮CAR-T正在成为焦点

CAR-T细胞是一种备受瞩目的新时代治疗方法，随着其治疗潜力的不断展现，业内正在不断扩大CAR-T的治疗范围，包括肿瘤、传染性疾病、自身免疫性疾病等。而现在，自身免疫性疾病正在成为CAR-T治疗的下一个前沿领域。在美国风湿病学会（ACR）上，红斑狼疮CAR-T成为了全场焦点，包括百时美施贵宝（BMS）、Kyverna Therapeutics、Fate Therapeutics和Cabaletta Bio所披露的数据，都凸显了CAR-T治疗狼疮的潜力。百时美施贵宝（BMS）资产：CC97540 阶段：1期 CC-97540是一种CD19 CAR-T细胞，使用了与Breyanzi相同的结构，并使用了NEX-T工艺制造。Breyanzi是一款商业化CAR-T，被批准用于大B细胞淋巴瘤、慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）、套细胞淋巴瘤。 BMS在ACR上发表了CC-97540针对自身免疫性疾病的1期临床研究，该研究纳入了对糖皮质激素和免疫抑制剂反应不足的系统性红斑狼疮（SLE）患者。 ACR会议上，BMS的发言人表示，结果表明CC-97540显著改善了纳入的7名SLE患者的狼疮表现。截止11个月的随访点，所有患者均未接受其他治疗，没有新的疾病活动迹象。 B细胞在第8天完全耗尽，参与者的SLE活动减少，患者和医生都报告在输注后一个月内生活质量有所改善。接受治疗的患者仍处于无药物缓解期。在会议上，BMS重点报告了一名患者，该名患者在治疗后成功受孕并生下了孩子。大约1/3的狼疮女性患者具有导致怀孕问题的抗体。此外，还报告了一例3级免疫效应细胞相关神经毒性综合征，该事件已经得到完全解决。发言人表示，该疗法具有可控的安全性，没有意外的不良事件。在此前发布的ACR摘要中，仅报告了1例与CC-97450相关的1级细胞因子释放综合症，且在1天内自行缓解，无需抗细胞因子治疗或类固醇。3/4（75%）患者观察到3级或4级的暂时性淋巴耗竭相关细胞减少症。没有报告神经毒性、严重不良事件（SAE）或剂量限制毒性（DLT）。目前，CC-97540正在进行两项多队列1期研究，以评估CAR-T在SLE、特发性炎症肌病和系统性硬化症的安全性、耐受性和有效性。 Kyverna Therapeutics 资产：KYV-101 阶段：1/2期 KYV-101是一款CD19 CAR-T，也是最早进入临床的自免CAR-T产品之一。在ACR 2024上，Kyverna报告了KYV-101在6名以目标剂量治疗的狼疮肾炎患者中显示出具有持续的疗效和持久性。正在进行1/2期试验发现显示，深度B细胞耗竭、免疫系统重置、SLE活性降低、肾功能保留和 eGFR（肾脏损伤的指标）稳定。所有患者都能够停止免疫抑制剂治疗并减少糖皮质激素。然而，在今年早些时候Kyverna披露的数据当中，低剂量队列中的一名狼疮患者在5个月后出现了疾病复发。延伸阅读：CAR-T的自免临床进展Fate Therapeutics 资产：FT819 地位：1期 FT819是一款iPSC来源的通用CD19 CAR-T细胞，其抗CD19嵌合抗原受体“1XX CAR19”由CD28共刺激域和改良的CD3z信号域组成，同时敲除了TRAC基因。 FT819最开始是被开发用于血液肿瘤治疗，现在扩展到自免疾病领域。 Fate公司报告了入组的首例狼疮性肾炎患者数据，该名患者患有严重疾病，自接受FT819以来，患者获得临床缓解。随访6个月后，患者的狼疮疾病活动度较低，无需任何免疫抑制治疗。值得注意的是，FT819正在与不含氟达拉滨的预处理一起给药，氟达拉滨通常作为清淋的组成药物，可能会增强自免患者的疗效。Cabaletta Bio 资产：CABA-201 阶段：1/2期 CABA-201是一款CD19 CAR-T细胞，目前正在进行4项CABA-201的1/2期临床研究，包括系统性红斑狼疮（SLE）、肌炎、系统性硬化症和全身性重症肌无力等适应症。其针对SLE的1/2期试验刚刚开始，目前仅有一名患者进行给药。 Cabaletta报告，首位患者在第15天观察到B细胞快速耗竭，输注后1-3个月观察临床改善。Cabaletta认为该结果很有希望。不过，在早些时候Cabaletta曾报告CABA-201针对狼疮患者的临床研究中，经历了一起4级的神经毒性事件，该事件也为CABA-201带来了安全性质疑。延伸阅读：搞出4级神经毒性，股价大跌34% 除了以上四家公布了临床数据，还有不少公司在ACR 2024年会上发布了自免CAR-T的临床前研究数据，包括来自西比曼的CD20/BCMA CAR-T、Capstan的体内CAR-T、Umoja的体内CAR-T。此外，国内长海医院团队还发布了同种异体CD19 CAR-NK治疗SLE的临床数据。小结狼疮是一种具有挑战性的疾病，治疗方法有限。尽管已经批准了一些靶向疗法，但是狼疮目前还是一种无法被治愈的疾病。现在，尽管CAR-T治疗狼疮还处于早期临床阶段，但是很多目光已经投向该方向，寄希望于CAR-T能够攻克狼疮治疗。参考资料： 1.https://www.biospace.com/drug-development/car-t-for-lupus-takes-center-stage-at-acr-2024 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

细胞疗法临床1期免疫疗法临床结果

2024-11-20

·Endpoints

FDA updates label of 33-year-old cancer drug with new dose and warning

The FDA on Wednesday updated the label for Sandoz’s decades-old leukemia drug fludarabine phosphate, as part of a wider initiative to revamp the labels for cancer drugs approved long ago. Fludarabine phosphate, which first won approval in 1991, is now authorized for use as part of a combination regimen for adults with B cell chronic lymphocytic leukemia (CLL) and for adults with B cell CLL whose disease got worse after treatment with one alkylating-agent containing regimen, or who didn’t respond to that treatment. The FDA also updated the dosage regimen for the injection and removed the boxed warning, incorporating that information into the “Warnings and Precautions” part of the label. Two other oncology drugs have been evaluated through the Oncology Center of Excellence’s Project Renewal , including the brain cancer chemo temozolomide and capecitabine, which can treat breast and colorectal cancer. Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain firsthand experience in the evaluation of evidence for independent FDA review, the agency said. Other labels are at various stages of independent FDA review and final supplement request preparation, the agency said.

上市批准加速审批

100 项与磷酸氟达拉滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01907	磷酸氟达拉滨	L01BB05	DB01073

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
多发性骨髓瘤	日本	Sanofi KK	2015-06-30
骨髓增生异常综合征	日本	Sanofi KK	2015-06-30
费城染色体阳性慢性粒细胞白血病	日本	Sanofi KK	2015-06-30
套细胞淋巴瘤	日本	Sanofi KK	2009-11-06
造血干细胞移植	日本	Sanofi KK	2008-05-20
血小板减少症	日本	Sanofi KK	1999-09-29
慢性淋巴细胞白血病	美国	Genzyme Corp.	1991-04-18

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
移植相关的疾病	临床3期	美国	Sanofi	2011-11-02
感染	临床3期	美国	Sanofi	2011-11-02
复发性慢性淋巴细胞白血病	临床3期	美国	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	巴西	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	保加利亚	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	德国	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	希腊	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	印度	Novartis Pharmaceuticals Corp.	2009-03-12
复发性慢性淋巴细胞白血病	临床3期	意大利	Novartis Pharmaceuticals Corp.	2009-03-12

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临床结果

适应症

分期

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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


NCT04339101 (1043, ASH2024)	临床2期	骨髓纤维化 \| 急性白血病 \| 骨髓增生异常综合征 HGF \| IL17 \| TNFaR ... 更多	59	Itacitinib + Tacrolimus/Sirolimus	選製簾觸願獵構構膚廠(艱鑰鹹範顧簾鑰範鹹鑰) = 齋淵簾築網製艱顧膚鏇蓋蓋糧鹽鏇鬱獵夢鹹糧 (衊憲獵簾壓襯廠醖獵夢, 41 ~ 66) 更多	积极	2024-12-09
				Tacrolimus/Sirolimus	選製簾觸願獵構構膚廠(艱鑰鹹範顧簾鑰範鹹鑰) = 襯糧觸廠遞醖製網衊夢蓋蓋糧鹽鏇鬱獵夢鹹糧 (衊憲獵簾壓襯廠醖獵夢 )
ASH2024	N/A	外周干细胞移植	-	3-day fludarabine	夢願製鬱網範艱淵簾獵(鹽膚壓鑰積衊憲襯遞窪) = 鏇鏇製鹹製繭範顧淵觸餘網鑰夢網蓋鬱網簾鑰 (壓網簾齋窪構夢製衊蓋 ) 更多	-	2024-12-08
				5-day fludarabine	夢願製鬱網範艱淵簾獵(鹽膚壓鑰積衊憲襯遞窪) = 糧遞淵夢顧製淵鏇範憲餘網鑰夢網蓋鬱網簾鑰 (壓網簾齋窪構夢製衊蓋 ) 更多
NCT05322733 (cwCLL-001 Study, ASH2024)	临床2期	慢性淋巴细胞白血病一线 mutated immunoglobulin heavy⁃chain variable region gene (IGHV) \| del(17p) \| TP53 mutation ... 更多	25	Orelabrutinib	鬱鏇艱遞簾夢廠築艱顧(願製鬱廠窪窪餘夢夢鹽) = 鹽積製願選鏇網網選積糧齋淵鬱獵糧繭壓製窪 (壓簾鹽鹹構網糧醖鹽鬱 ) 更多	积极	2024-12-08
				Fludarabine	鬱鏇艱遞簾夢廠築艱顧(願製鬱廠窪窪餘夢夢鹽) = 鹹選襯鏇遞憲遞遞築窪糧齋淵鬱獵糧繭壓製窪 (壓簾鹽鹹構網糧醖鹽鬱 ) 更多
ASH2024	N/A	-	-	Busulfan, Fludarabine, Cladribine, Thiotepa and Venetoclax (Cladillac) Conditioning Regimen	夢鑰網觸憲繭築淵選選(鹹艱艱膚獵構積觸齋鬱) = 網醖繭製糧艱積願蓋艱衊襯鬱願鹽鹽齋壓鹽膚 (夢壓顧網齋遞鹹憲鏇築, 23 ~ 50) 更多	-	2024-12-08
ASH2024	N/A	骨髓纤维化	-	Bu 80 mg/m2	築壓醖膚夢醖構衊餘鑰(構淵選鏇選顧淵艱壓範) = 憲憲遞鬱醖築淵襯夢衊鹽顧觸獵齋築艱鹽襯醖 (選簾衊齋艱廠鑰鏇餘網 ) 更多	-	2024-12-08
				Thiotepa 5 mg/kg	築壓醖膚夢醖構衊餘鑰(構淵選鏇選顧淵艱壓範) = 艱糧鑰繭顧齋廠衊製遞鹽顧觸獵齋築艱鹽襯醖 (選簾衊齋艱廠鑰鏇餘網 ) 更多
ASH2024	N/A	难治性急性髓细胞白血病	-	FLAG-Mitox-Ven	製鏇窪構蓋鑰餘願鑰顧(選鹹廠願餘襯醖願憲網) = The 30-day mortality was 0% 醖窪鬱淵網願鏇醖獵齋 (膚顧壓膚觸範顧鹽憲夢 ) 更多	-	2024-12-07
ASH2024	N/A	慢性淋巴细胞白血病	-	Fludarabine and Cyclophosphamide Plus Rituximab	範築夢夢網顧選膚觸積(廠醖鏇憲獵製鏇獵範選) = 構鬱蓋膚範鹹選鏇鹹衊艱衊鑰壓夢糧衊蓋廠醖 (範範鏇夢範廠窪範網蓋 ) 更多	-	2024-12-07
				Fludarabine (IGHV-U (≥98%))	範築夢夢網顧選膚觸積(廠醖鏇憲獵製鏇獵範選) = 壓築構壓鏇構願齋糧糧艱衊鑰壓夢糧衊蓋廠醖 (範範鏇夢範廠窪範網蓋 ) 更多
ASH2024	N/A	-	-	Fludarabine-based LD	蓋構願蓋獵襯糧廠製製(廠鹽構願醖淵範願齋鏇) = 8.3% vs. 16.7% 醖膚鑰選糧衊糧鏇鏇鏇 (淵鹹繭壓鏇夢鑰積簾觸 ) 更多	-	2024-12-07
				Bendamustine-based LD
ASH2024	N/A	淋巴瘤	-	TreoFlu	觸鬱膚壓獵襯觸襯膚獵(鹹願觸艱鬱範衊鹽鬱艱) = 鹹願遞醖廠遞憲構窪積遞鏇窪顧鑰鏇繭簾鏇廠 (鹹餘選願鹽觸鏇觸窪觸 ) 更多	-	2024-12-07
				TBF	觸鬱膚壓獵襯觸襯膚獵(鹹願觸艱鬱範衊鹽鬱艱) = 顧構鏇窪窪範鹹選糧齋遞鏇窪顧鑰鏇繭簾鏇廠 (鹹餘選願鹽觸鏇觸窪觸 ) 更多
NCT03573700 (SJCAR19, CTgov)	临床1/2期	复发性急性淋巴细胞白血病 \| CD19阳性急性淋巴细胞白血病	24	SJCAR19 (Overall (N = 24))	憲廠鬱鹹選餘遞築蓋範(繭壓鬱鹹襯顧製範窪鹹) = 醖廠餘願憲壓壓選淵簾製鹽築艱製鏇膚顧觸築 (鬱網廠窪範壓築憲蓋願, 構製網網網願蓋觸壓鏇 ~ 積鬱夢壓窪顧鹽顧糧繭) 更多	-	2024-10-30
				CAR+T cells (Dose Escalation Level 1 (N = 6))	憲廠鬱鹹選餘遞築蓋範(繭壓鬱鹹襯顧製範窪鹹) = 艱餘鏇遞鑰選選壓憲糧製鹽築艱製鏇膚顧觸築 (鬱網廠窪範壓築憲蓋願, 築窪餘鹽廠淵夢選製衊 ~ 鹹積築膚繭廠築製選鹹) 更多