利妥昔单抗生物类似药 (mAbxience)(Rituximab biosimilar (mAbxience)) - 药物靶点：CD20_在研适应症：弥漫性大B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Rituximab Biosimilar (mAbxience SA)、利妥昔单抗生物类似药（mAbxience SA）

+ [2]

靶点

CD20

作用机制

CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用

+ [1]

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病

在研适应症

弥漫性大B细胞淋巴瘤

非在研适应症-

原研机构

mAbxience SA

在研机构

mAbxience SA

非在研机构

mAbxience Research SL

最高研发阶段批准上市

首次获批日期

阿根廷 (2015-01-01),

弥漫性大B细胞淋巴瘤

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 83181H

当前序列信息引自: *****

Sequence Code 27145L

当前序列信息引自: *****

关联

4

项与利妥昔单抗生物类似药 (mAbxience) 相关的临床试验

NCT04146103 / CompletedN/AIIT

Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.

开始日期2018-04-01

申办/合作机构

St. Joseph's University

CTRI/2014/09/004959 / Recruiting临床3期

A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line.

开始日期2014-09-19

申办/合作机构

mAbxience SA

NCT02268045 / Completed临床3期

A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line

This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).
Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.

开始日期2013-05-01

申办/合作机构

mAbxience Research SL

[+7]

100 项与利妥昔单抗生物类似药 (mAbxience) 相关的临床结果

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100 项与利妥昔单抗生物类似药 (mAbxience) 相关的转化医学

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100 项与利妥昔单抗生物类似药 (mAbxience) 相关的专利（医药）

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10

项与利妥昔单抗生物类似药 (mAbxience) 相关的文献（医药）

2024-09-01·Oncology and Therapy

Long-Term Safety and Effectiveness of Rituximab Biosimilar RTXM83: A Retrospective Extension Study in Brazilian Patients with Diffuse Large B-Cell Lymphoma

Article

作者: Pereira, Juliana ; Pericole, Fernando Vieira ; Werutsky, Gustavo ; Cardoso, Ana Carolina Ferreira ; Delamain, Marcia Torresan ; Higashi, Marcia ; da Silva, Roberto Luiz ; de Paulo Giacon Radtke, Patrícia ; da Silva Araújo, Sérgio Shusterschitz ; Castilho, Vivienne ; Fogliatto, Laura ; Salvino, Marco Aurélio

INTRODUCTIONRTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption.METHODSIn this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01-11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment.RESULTSThe median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group.CONCLUSIONThis study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT04928573. June 16, 2021, "retrospectively registered".

2022-01-01·Current Research in Pharmacology and Drug Discovery

Comparative differential cytotoxicity of clinically used SERMs in human cancer lines of different origin and its predictive molecular docking studies of key target genes involved in cancer progression and treatment responses

Article

作者: G, Rajmohan ; A, Shanitha ; S, Lakshmi ; Sharaf, Shehna ; R, Saikant ; Bs, Rahul ; Dv, Shiny ; Sa, Abi

SERMS like Tamoxifene, 5-hydroxy tamoxifene, raloxifene and endoxifene has been used for the treatment of hormonal imbalances and dependent cancers owing to their action via Estrogen receptors as in the treatment of estrogen sensitive breast cancers. Due to the adverse side effects, modifications and development of the existing or newer SERMS has always been of immense interest. Ormeloxifene, a SERM molecule manufactured by HLL Lifecare Ltd, India as birth control under the trade names Saheli, Novex, and Novex-DS which is also investigated against mastalgia, fibro-adenoma and abnormal uterine bleeding. Anti-cancer effects have been reported in estrogen dependent and independent cancers which shows its wide scope to be implemented in cancer therapy. Current investigation is a comprehensive effort to find the cytotoxic potential of Ormeloxifene in comparison with clinically used four SERMS in twenty six cancer cell lines of different origin using Adriamycin as positive control. Also the computational studies pertaining to selected target/ligand with respect to tumor progression, development, treatment responses and apoptosis. The studies proved effective cytotoxicity of Ormeloxifene on cancer cell lines with lower TGI, GI50 and LC₅₀ values which are significantly comparable. Also the in silico studies proved that the docking score of the compound suggests the interaction of the compound which could tightly regulate key target genes controlling cancer like ER, EGFR kinase, EGFR-cSRC, HDAC-2, PARP-1 and BRAF. This study brings out the superior efficacy of Ormeloxifene compared to other SERMS with proven safety profile to be repositioned as an anti-cancer drug to treat diverse cancer types.

2021-11-01·Journal of Pharmacy and Bioallied Sciences

Evaluating the Effect of Ormeloxifene on Multiple Fibroadenomas and Mastalgia

Article

作者: Patil, Pooja ; Vasuniya, Vikram ; Brahmachari, Swagata ; Bhagat, Vaishali

Introduction:Most common benign breast conditions presenting in the breast clinics include fibroadenomas and mastalgia, both these conditions cause considerable anxiety in the patients. Among other treatment modalities, the hormonal drug treatments are gaining popularity. Ormeloxifene (centchroman) is an antiestrogenic drug which is shown to have effect in reducing the pain in mastalgia patients and the size of fibroadenoma.Objectives:Ormeloxifene is selective antiestrogen and a nonsteroidal drug. It has a discerning antiestrogen action and hence is useful for the treatment of mastalgia and multiple small fibroadenomas. Hence, the objective of our study was to assess the effect of Ormeloxifene (centchroman) on multiple fibroadenoma and mastalgia.Materials and Methods:Patients with benign breast disease attending our surgery outpatient department from June 2016 to July 2017. Patients were started on Ormeloxifene 30 mg on alternate days for a period of 3 months. Patients were followed up to 6 months after the inception of the study. Parameters recorded include the Visual Analog Scale (VAS) for pain and ultrasonography for breast lump size.Results:Thirty patients were included in the study. We found very good response in the mastalgia; the VAS scores in these patients dropped from 10 to 3 in 90% in the 1st week of introduction of the drug, and at the end of 1 month, almost all of the patients were painless. Overall final response was noted in terms of complete dissolution and change in the size was noted in 34% partial response in 46 %, no changes in 17 % and increase in size of fibroadenoma was noted in only one case.Conclusion:Novex is proved to be safe drug for the treatment of mastalgia and fibroadenoma. Its results were great in mastalgia group. At the end of 6 months, the number of surgeries (if needed) decrease and there is considerable improvement in the patient satisfaction rate.

100 项与利妥昔单抗生物类似药 (mAbxience) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	阿根廷	mAbxience SA	2015-01-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	临床1期	巴拉圭	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	俄罗斯	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	印度	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	印尼	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	墨西哥	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	哥伦比亚	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	巴西	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	菲律宾	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	临床前	南非	mAbxience Research SL	2013-05-01
弥漫性大B细胞淋巴瘤	药物发现	伊朗	mAbxience Research SL	2013-05-01

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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


Novex (ICML2017)	N/A	淋巴瘤	583	NOVEX®	(網鹹築鬱鹽淵壓糧餘餘) = 1 觸獵憲遞糧積鏇積壓選 (鏇壓夢構糧鹽願顧壓餘 ) 更多	积极	2017-06-07