更新于：2024-07-01

Pralatrexate

普拉曲沙

更新于：2024-07-01

概要

概要

基本信息

药物类型

小分子化药

别名

(2S)-2-((4-((1RS)-1-((2,4-Diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid、(2S)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid、10-Propargyl-10-deazaaminopterin

+ [7]

靶点

DHFR

作用机制

DHFR抑制剂(二氢叶酸还原酶抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [2]

在研适应症

外周T细胞淋巴瘤复发型外周T细胞淋巴瘤难治性外周T细胞不明淋巴瘤+ [11]

非在研适应症

食管腺癌晚期非小细胞肺癌晚期恶性实体瘤+ [23]

原研机构

Memorial Sloan Kettering Cancer Center

在研机构

Allos Therapeutics, Inc.

Mundipharma International Ltd.Mundipharma Medical Co.

+ [6]

非在研机构

Spectrum Pharmaceuticals, Inc.Allos Therapeutics Ltd.

Memorial Sloan Kettering Cancer Center

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2009-09-24),

外周T细胞淋巴瘤

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)

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结构

分子式C23H23N7O5

InChIKeyOGSBUKJUDHAQEA-WMCAAGNKSA-N

CAS号146464-95-1

关联

项与普拉曲沙相关的临床试验

NCT06072131 / Recruiting临床3期

A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study.
Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to 6 cycles. The primary objective is to compare the Progression Free Survival of patients with newly diagnosed PTCL treated for up to 6 cycles with Beleodaq (belinostat) in combination with CHOP (Bel-CHOP) or Folotyn (pralatrexate injection) in combination with COP (Fol-COP) to CHOP alone.

开始日期2023-10-04

申办/合作机构

Acrotech Biopharma LLC初创企业

NCT03240211 / Recruiting临床1期IIT

Novel Immuno-epigenetic Based Platform for Patients With Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-cell Lymphoma (CTCL): an International Phase Ib Study of Pembrolizumab Combined With Decitabine and/or Pralatrexate

This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine.

开始日期2022-02-02

申办/合作机构

University of Virginia

[+2]

NCT03719105 / Recruiting早期临床1期IIT

Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Patients are in 2 cohorts:
Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX) (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide, doxorubicin, and prednisone in children, adolescent, and young adults with advanced peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) .
Both groups proceed to allogeneic stem cell transplant with disease response.

开始日期2019-03-01

申办/合作机构

New York Medical College

[+1]

100 项与普拉曲沙相关的临床结果

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100 项与普拉曲沙相关的转化医学

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100 项与普拉曲沙相关的专利（医药）

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415

项与普拉曲沙相关的文献（医药）

2024-02-01·International journal of biological macromolecules

Electrospun polydioxanone/fucoidan blend nanofibers loaded with anti-cancer precipitate from Jaspis diastra and paclitaxel: Physico-chemical characterization and in-vitro screening

Article

作者: Ramanjooloo, Avin ; Goonoo, Nowsheen ; Chummun Phul, Itisha ; Bhaw-Luximon, Archana

Nanofibers for drug delivery systems have gained much attention during the past years. This paper describes for the first time the loading of a bioactive precipitate (JAD) from the marine sponge Jaspis diastra in PDX and fucoidan-PDX. JAD was characterized by LC-MS/MS and the major component was jaspamide (1) with a purity of 62.66 %. The cytotoxicity of JAD was compared with paclitaxel (PTX). JAD and PTX displayed IC₅₀ values of 1.10 ± 0.7 μg/mL and 0.21 ± 0.12 μg/mL on skin fibroblasts L929 cells whilst their IC₅₀ values on uveal MP41 cancer cells, were 2.10 ± 0.55 μg/mL and 1.38 ± 0.68 μg/mL, respectively. JAD was found to be less cytotoxic to healthy fibroblasts compared to PTX. JAD and PTX loaded scaffolds showed sustained release over 96 h in physiological medium which is likely to reduce the secondary cytotoxic effect induced by JAD and PTX alone. The physico-chemical properties of the loaded and unloaded scaffolds together with their degradation and action on tumor microenvironment by using L929 and MP41 cells were investigated. JAD and PTX at a concentration of 0.5 % (drug/polymer, w/w) in the electrospun mats prevented growth and proliferation of L929 and MP41 cells. Co-culture of L929 and MP41 showed that the JAD and PTX loaded mats inhibited the growth of both cells and caused cell death.

2024-01-23·Blood advances

Pralatrexate injection combined with CHOP for treatment of PTCL: results from the Fol-CHOP dose-finding phase 1 trial

Article

作者: Barta, Stefan K ; Iyer, Swaminathan P ; Johnston, Patrick B

Abstract:

Pralatrexate is a folate antagonist that selectively enters cells expressing reduced folate carrier type 1 and competitively inhibits dihydrofolate reductase, leading to interruption of RNA synthesis, DNA replication, and apoptosis. This phase 1 study was conducted to evaluate the maximum tolerated dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen (part 1) and the response and pharmacokinetics of 6 cycles of this combination (CHOP + Folotyn 30 mg/m2 [Fol-CHOP]) in patients with newly diagnosed peripheral T-cell lymphoma (PTCL). In part 1, on days 1 and 8 of each cycle, patients were treated with 10, 15, 20, 25, or 30 mg/m2 of pralatrexate in combination with CHOP, per dose escalation, in 5 sequential cohorts. No patients experienced DLTs in cohorts 1, 2, 3, 4, and 5. The pralatrexate dose of 30 mg/m2 was selected to be combined with CHOP for part 2 and administered to 33 additional patients in the expansion cohort. At the MTD, the Fol-CHOP regimen was generally well tolerated in patients with PTCL, with an overall response rate (ORR) of 83.9% (20 complete response and 6 partial response), as assessed by treating investigators. Thirty-five patients (67.3%) experienced grade 3/4 treatment-emergent adverse events, the most common of which were anemia (21.2%), neutropenia (19.2%), febrile neutropenia (11.5%), fatigue, mucosal inflammation, nausea, and vomiting (7.7% each). In conclusion, Fol-CHOP was found to be a safe and effective treatment for newly diagnosed PTCL and deemed worthy of further investigation. This trial was registered at www.ClinicalTrials.gov as #NCT02594267.

2024-01-01·Antiviral research

Pralatrexate inhibited the replication of varicella zoster virus and vesicular stomatitis virus: An old dog with new tricks

Article

作者: Nawaz, Waqas ; Zhu, Haotian ; Lyu, Ruining ; Zhang, Fang ; Tao, Hongji ; Wu, Jing ; Cai, Yurong ; Jiang, Na ; Chen, Deyan ; You, Qiao ; Wu, Zhiwei ; Qian, Yajie

Varicella zoster virus (VZV) is associated with herpes zoster (HZ) or herpes zoster ophthalmicus (HZO). All antiviral agents currently licensed for the management of VZV replication via modulating different mechanisms, and the resistance is on the rise. There is a need to develop new antiviral agents with distinct mechanisms of action and adequate safety profiles. Pralatrexate (PDX) is a fourth-generation anti-folate agent with an inhibitory activity on folate (FA) metabolism and has been used as an anti-tumor drug. We observed that PDX possessed potent inhibitory activity against VZV infection. In this study, we reported the antiviral effects and the underlying mechanism of PDX against VZV infection. The results showed that PDX not only inhibited VZV replication in vitro and in mice corneal tissues but also reduced the inflammatory response and apoptosis induced by viral infection. Furthermore, PDX treatment showed a similar anti-VSV inhibitory effect in both in vitro and in vivo models. Mechanistically, PDX inhibited viral replication by interrupting the substrate supply for de novo purine and thymidine synthesis. In conclusion, this study discovered the potent antiviral activity of PDX with a novel mechanism and presented a new strategy for VZV treatment that targets a cellular metabolic mechanism essential for viral replication. The present study provided a new insight into the development of broad-spectrum antiviral agents.

项与普拉曲沙相关的新闻（医药）

2024-06-26

·PRNewswire

CASI Pharmaceuticals Announces Plan To Submit IND Application For CID-103, an Anti-CD 38 Antibody in Antibody-Mediated Rejection, and Receipt of a Non-Binding Proposal to Acquire Entire China Business of the Company

BEIJING, June 26, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, announced today that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. The Company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR. CASI also announced that its board of directors (the "Board") received a preliminary non-binding proposal letter (the "Proposal Letter") dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company's pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the "Proposed Transaction"). On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the "Special Committee") to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company's business operations in China. The Board and the Special Committee caution the Company's shareholders and others considering trading the Company's securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Proposed Transaction or that any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. Forward-Looking Statements This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. COMPANY CONTACT: Rui Zhang CASI Pharmaceuticals, Inc. 240.864.2643 [email protected] SOURCE CASI Pharmaceuticals

临床申请临床2期临床1期

2024-06-19

·Firstwordpharma

Dizal's JAK1 drug gets China nod for peripheral T-cell lymphoma

Chinese regulators have approved Dizal's JAK1 inhibitor golidocitinib for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).The decision makes it "the world's first JAK1-only inhibitor" for PTCL patients, noted CEO Xiaolin Zhang, as well as the second approved drug from Dizal after the AstraZeneca spinout's lung cancer treatment sunvozertinib was waved through in China last year.While a few drugs have been granted conditional regulatory approvals in the relapsed or refractory PTCL setting, Dizal noted that their single-agent activities have been "modest," with objective response rates (ORRs) below 30%.During an advisory panel meeting last November, the FDA raised questions about accelerated approvals for Acrotech Biopharma's folate analogue inhibitor Folotyn (pralatrexate) and HDAC inhibitor Beleodaq (belinostat) in relapsed/refractory PTCL after both their confirmatory trials experienced major delays.However, Dizal says its drug has demonstrated "superior and durable" clinical benefits in the pivotal JACKPOT8B study, compared with these existing treatment options. Data from the trial presented last year showed an ORR of 44.3% with golidocitinib, including a 23.9% complete response rate.Median duration of response was 20.7 months and 53.8% of patients were still responding. Moreover, tumour responses were observed across various PTCL subtypes. Results of the JACKPOT8 trial have been published in Annals of Oncology and The Lancet Oncology."With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumour efficacy with a favourable safety profile," the company said.

上市批准加速审批临床结果

2024-05-07

·药智网

加速批准是免死金牌吗？

凭借FDA“加速批准”政策上市的药物，在上市后研究未能达到预期标准的情况下，FDA并未撤回审批，“加速批准”政策是否已成为某些药品的免死金牌？01FDA为何无动于衷？大多数情况下，FDA面对这些无效的上市后研究之所以选择“引而不发”，在很大程度上是这些药物身上的“未满足领域唯一疗效”的标签所决定的。尽管这所谓的唯一疗法在上市后研究中没有表现出期待的疗效，但这些“尾大不掉”的上市药物还是令FDA有些投鼠忌器的感觉。一旦将这些药物从市场上撤下，那么已经开始使用这些药物的患者又将重回无药可用的状态。然而，继续让患者使用无法被证明有效的药物，虽然可能在心理上或许能够给患者一些安慰，但在病情的拖延和浪费的成本方面所造成的损失也是显而易见的。FDA在进退维谷的局面中感受到压力，但如果他们选择将一款没有通过临床终点的药物保留在市场上，至少应该向公众阐明他们这种选择的理由。FDA应该向公众坦诚，他们为什么会选择与开发商进行协商，设计并开展进一步的研究。同时也有义务解释，为什么其它某些药物在未能通过上市后研究的情况下被FDA撤回了加速批准。02FDA有无区别对待？从另一个角度看，FDA也在努力清除上市后研究无效的加速批准。例如他们从2021年开始整肃一组PD-1/L1抑制剂的加速批准，这些适应症的上市后试验已完成，但未能验证临床效益，包括针对10个适应症的4种药物，最终制药商撤回了4个适应症。FDA在解释对上市后研究失败药物的区别对待，即为什么有的公司可以获得继续上市后研究的机会，而有的公司的加速审批被撤销这一现象时，FDA认为公司的规模对上市后研究的行为起到了重要的影响。很多大公司在进行上市后的验证研究中设计了多项临床试验，因此当一项失败时，他们仍然有回旋的余地，FDA也有耐心等待其它研究结果的出炉。例如当年默沙东的Keytruda在针对肝癌获得加速批准之后，它的上市后三期临床研究Keynote-240失败，但FDA并没有立即取消它的加速批准，这主要是因为FDA之前已经批准了Keytruda针对肝癌的其它上市后临床研究Keynote-394，在这种情况下，FDA通常不会立即做出取消加速批准的决定，而是将等待其它研究结果的出炉。Keynote-394最终达到了临床终点，并最终得到了Keytruda针对肝癌的全面批准。与之形成对比的是很多小型制药公司，他们获得加速批准的那款药物可能就是公司唯一上市资产。他们并不情愿像BMS那样主动撤回申请，但又宣称没有资金进行多线验证性研究，从而造成一旦唯一的验证性试验失败就无以为继的局面。除此之外，大型制药公司在加速批准后准备上市后研究的过程中更愿意与FDA加强互动，并且在获得加速批准之前就开始着手准备上市后验证研究，这恰好也是新的FDORA法案（《食品和药品综合改革法案》）赋予FDA的权力，允许FDA要求申办者在获得加速审批之前就开始验证性研究。FDORA法案还赋予了FDA面对那些拒绝自愿撤回加速批准产品或者适应症的申办者时，可以启动快速撤回程序，但允许申办者进行上诉或者与FDA专员会面。03如何权衡？上市后验证性研究未能证实药效却未被撤回，是药物审批和监管领域中一个备受争议的问题。FDA在加速批准时通常要求制药公司进行后市场验证性研究，以确认药物的实际效果。然而，当这些研究未能证实预期的益处时，一些药物可能仍然保留在市场上，因为FDA可能认为尚有一些患者可能从中获益，或者因为缺乏其他治疗选择。监管机构通常需要权衡药物的安全性和效果。即使验证性研究未能证实药物的临床益处，如果药物被认为对某些患者仍有积极作用，监管机构可能不会立即撤回批准，以确保患者有继续治疗的选择。一些人认为，这种情况反映了对新药审批标准的降低，以便更快地推出新药。他们担心，这可能导致一些药物在上市后未能充分证实其益处，却仍然继续销售。这种情况强调了对信息透明度的需求，包括在药物上市后追踪其效果和安全性，并向医生和患者提供准确的信息，以便做出明智的治疗决策。解决FDA面临的上市后验证性研究未能证实药效但未被撤回的问题需要综合考虑多个因素，包括患者需求、药物安全性和有效性、科学证据以及公共健康。以下是一些建议：强化信息透明度：FDA可以加强对于药物上市后的监管和信息透明度，确保医生和患者能够获得最新的临床数据。这有助于更全面地了解药物的实际效果和安全性。明确后市场研究要求：FDA可以在药物获得加速批准时明确规定后市场验证性研究的要求，并确保这些研究有足够的样本量和持续时间，以充分评估药物的效果和安全性。灵活性与严谨性的平衡：在审批和监管过程中，FDA需要在灵活性和严谨性之间寻找平衡。这意味着在加速批准的情况下，仍要确保对新药的审查具有足够的科学依据，而后市场监管也要持续进行。加强专家咨询：FDA可以更积极地与医学专家、研究人员和患者群体进行合作，获取更全面的意见。这有助于更好地理解特定药物对患者的真实效果和需求。实施更严格的审查标准：鉴于加速批准可能涉及降低一些审查标准，FDA可以考虑加强对加速批准申请的审查，以确保科学证据的充分性。激励药企完成后市场研究：FDA可以采取激励措施，鼓励制药公司完成后市场验证性研究，确保及时获得更多的数据来支持药物的安全性和有效性。这些建议的实施需要平衡各方的利益，并考虑到公共健康的整体目标。FDA在决策中需要权衡各种因素，以确保患者能够获得安全、有效的治疗，并确保医学进步的同时不牺牲科学严谨性。Ref.1.Sutter,S.Amgen’s Lumakras:FDA Flags‘Marginal’Efficacy Results,Potential Systemic Bias In Lung Cancer Trial.Pink Sheet.03.10.2023.2.Sutter,S.Confirmatory Trial Plan For Acrotech’s Folotyn,Beleodaq Needs Rethinking,FDA Panel Says.Pink Sheet.05.10.2023.3.Sutter,S.US FDA In No Hurry To Withdraw Amgen’s Lumakras Despite Negative Adcomm Vote On Confirmatory Trial Results.Pink Sheet.05.10.2023.4.Bristol Myers Squibb Statement on Opdivo®(nivolumab)Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S.Indication.BMS Press Release.21.07.2021.5.Sutter,S.How Fast Is‘Expedited’?Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs.Pink Sheet.28.08.2023.6.Sutter,S.Pazdur On Accelerated Approval:FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail.Pink Sheet.30.01.2024.声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 德清君转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

加速审批临床3期

100 项与普拉曲沙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05589	普拉曲沙	L01BA05	DB06813

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
外周T细胞淋巴瘤	美国	Acrotech Biopharma LLC初创企业	2009-09-24

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
T细胞淋巴瘤	申请上市	欧盟	Allos Therapeutics Ltd.	-
复发型外周T细胞淋巴瘤	临床3期	中国	Allos Therapeutics, Inc.	2015-09-10
复发型外周T细胞淋巴瘤	临床3期	中国	AndersonBrecon, Inc.	2015-09-10
复发型外周T细胞淋巴瘤	临床3期	中国	萌蒂（中国）制药有限公司	2015-09-10
难治性外周T细胞不明淋巴瘤	临床3期	中国	Allos Therapeutics, Inc.	2015-09-10
难治性外周T细胞不明淋巴瘤	临床3期	中国	萌蒂（中国）制药有限公司	2015-09-10
难治性外周T细胞不明淋巴瘤	临床3期	中国	AndersonBrecon, Inc.	2015-09-10
肠病相关的T细胞淋巴瘤	临床2期	美国	National Cancer Institute	2019-02-04
蕈样真菌病	临床2期	美国	National Cancer Institute	2019-02-04
复发性间变性大细胞淋巴瘤	临床2期	美国	National Cancer Institute	2019-02-04

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01947140 (Pubmed)	临床2期	外周T细胞淋巴瘤	14	Pralatrexate 25 mg/m2 and Romidepsin 12 mg/m2	艱夢壓窪鹹蓋艱獵壓鹽(鏇醖憲鏇餘蓋襯繭夢鹽) = 製繭鹽網鹽鏇築鬱蓋廠鹹繭遞築鏇壓願艱壓築 (觸鏇範窪選廠範顧鬱鏇 ) 更多	-	2024-03-22
NCT02594267 (Fol-CHOP, Pubmed)	临床1期	外周T细胞淋巴瘤	33	CHOP + Folotyn 30 mg/m2 (Fol-CHOP)	簾鹹蓋壓觸範遞遞觸繭(鏇夢鬱壓鹽鑰窪築積壓) = 21.2% 積艱顧簾醖夢蓋艱鏇鹽 (網構廠蓋憲齋鹽願製顧 ) 更多	积极	2024-01-23
NCT01420679 (CTgov)	临床3期	外周T细胞淋巴瘤	21	Pralatrexate (Pralatrexate Arm)	觸夢鹹遞醖襯襯餘廠鑰(鏇簾願鏇遞簾窪簾壓獵) = 衊顧鹹齋膚觸憲餘艱鹽餘鏇膚選襯淵餘憲選繭 (鹹餘鑰襯醖鬱窪窪餘齋, 夢艱鬱齋選鹹衊獵構憲 ~ 醖願憲膚膚衊製築網選) 更多	-	2021-11-19
NCT01420679 (CTgov)	临床3期	外周T细胞淋巴瘤	21	vitamin B12+folic acid (Observation Arm)	觸夢鹹遞醖襯襯餘廠鑰(鏇簾願鏇遞簾窪簾壓獵) = 窪築繭繭醖壓築築築艱餘鏇膚選襯淵餘憲選繭 (鹹餘鑰襯醖鬱窪窪餘齋, 鑰鑰夢糧艱襯願醖餘構 ~ 獵獵餘膚觸網鑰憲衊餘) 更多	-	2021-11-19
NCT00998946 (CTgov)	临床2期	B细胞淋巴瘤	29	Vitamin B12+Pralatrexate	製壓願顧網蓋襯壓醖壓(齋齋築顧夢艱願積襯觸) = 願願鹹選夢糧窪糧獵選顧鬱遞觸蓋繭憲襯鬱鏇 (遞鹽鑰範窪築膚艱鹹製, 鬱齋願築餘醖遞廠窪艱 ~ 壓廠鹽繭鬱窪鹽願膚鏇) 更多	-	2021-11-05
NCT00052442 (CTgov)	临床1/2期	霍奇金淋巴瘤 \| 难治性侵袭性非霍奇金淋巴瘤 \| 难治性非霍奇金淋巴瘤	72	pralatrexate (135 mg/m^2 Pralatrexate 1/2 Weeks)	憲艱顧鏇範壓鏇壓淵顧(選顧窪蓋壓選鹹襯製窪) = 齋廠願窪鬱廠夢糧願願廠淵餘窪壓鏇築構選襯 (壓憲遞範夢艱顧構蓋鏇, 顧願壓衊構蓋觸獵膚繭 ~ 鑰鹹窪範憲簾蓋齋繭積) 更多	-	2021-08-25
NCT00052442 (CTgov)	临床1/2期	霍奇金淋巴瘤 \| 难治性侵袭性非霍奇金淋巴瘤 \| 难治性非霍奇金淋巴瘤	72	pralatrexate (30 mg/m^2 Pralatrexate 3/4 Weeks)	憲艱顧鏇範壓鏇壓淵顧(選顧窪蓋壓選鹹襯製窪) = 憲選簾餘襯壓顧膚鑰膚廠淵餘窪壓鏇築構選襯 (壓憲遞範夢艱顧構蓋鏇, 製壓壓觸醖積製願窪鏇 ~ 選憲鬱鏇繭積醖願鹽淵) 更多	-	2021-08-25
NCT03349333 (CTgov)	临床3期	复发性T细胞淋巴瘤 \| 难治性外周T细胞不明淋巴瘤	85	folic acid+pralatrexate	糧膚鏇繭膚鏇醖網鑰遞(衊願廠齋廠齋壓觸壓製) = 襯範簾淵鹹選鬱醖選鑰艱窪淵選膚範製鹹願製 (鑰選簾顧選築顧築選憲, 蓋餘遞範鏇壓鬱願廠繭 ~ 鹹蓋獵鏇製範鏇鏇蓋選) 更多	-	2019-09-12
EHA2019	N/A	复发性T细胞淋巴瘤	22	Pralatrexate	簾積獵糧醖壓壓襯窪構(鬱範餘糧鹹簾艱憲襯廠) = 壓艱選餘糧艱鑰築積衊膚廠選淵鏇願鑰繭簾膚 (鏇願積築襯蓋膚糧衊範 ) 更多	-	2019-06-15
EHA2019	N/A	非霍奇金淋巴瘤	10	Pralatrexate	製醖廠獵鬱齋壓壓遞願(餘構衊憲積窪構獵顧構) = Four patients required to be admitted at least in a cycle due to complications related to the treatment 蓋範夢艱鹽糧窪鹽衊製 (選顧糧遞鏇顧壓繭糧觸 ) 更多	-	2019-05-16
NCT03349333 (Pubmed \| Target Oncol) 人工标引	临床3期	外周T细胞淋巴瘤	71	Pralatrexate	觸獵製蓋艱窪簾顧窪壓(窪簾觸衊鑰廠蓋選窪襯) = 壓鏇憲獵觸遞膚鹽鏇鏇選餘鹹淵築蓋網衊夢鬱 (憲憲鏇願糧願鏇鏇觸網, 40 ~ 64) 更多	积极	2019-04-01
FOT12-CN-301 (ESMO_ASIA2018)	N/A	外周T细胞淋巴瘤	-	Pralatrexate IV 30mg/m2/wk	憲餘艱淵願艱壓繭網醖(顧憲鬱艱窪蓋窪遞製顧) = 膚淵構衊鏇膚製製鹹鏇襯願鑰願壓鑰餘鏇鏇構 (獵膚憲襯鹽醖艱觸窪襯, 40%, 64%) 更多	积极	2018-11-24