Gemtuzumab ozogamicin
(Synonyms: 吉妥珠单抗奥唑米星) 目录号 : GC64479
Gemtuzumab ozogamicin 是一种抗体偶联药物，由一种针对 CD33 的单克隆抗体组成，该单克隆抗体与 Calicheamicin 的细胞毒性衍生物相连。Gemtuzumab ozogamicin 可用于急性髓系白血病的研究。
Cas No.:220578-59-6
Sample solution is provided at 25 µL, 10mM.
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Quality Control & SDS
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Purity: >98.00%
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- Datasheet
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of Calicheamicin. Gemtuzumab ozogamicin can be used for the research of acute myeloid leukemia[1].
[1]. Baron J, et al. Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia. Expert Rev Clin Pharmacol. 2018;11(6):549-559.
| Cas No. | 220578-59-6 | SDF | Download SDF |
| 别名 | 吉妥珠单抗奥唑米星 | ||
| 分子式 | 分子量 | ||
| 溶解度 | 储存条件 | 4°C, do not freeze. | |
| General tips | 请根据产品在不同溶剂中的溶解度选择合适的溶剂配制储备液；一旦配成溶液，请分装保存，避免反复冻融造成的产品失效。 储备液的保存方式和期限：-80°C 储存时，请在 6 个月内使用，-20°C 储存时，请在 1 个月内使用。 为了提高溶解度，请将管子加热至37℃，然后在超声波浴中震荡一段时间。 |
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| Shipping Condition | 评估样品解决方案：配备蓝冰进行发货。所有其他可用尺寸：配备RT，或根据请求配备蓝冰。 | ||
| 第一步：请输入基本实验信息（考虑到实验过程中的损耗，建议多配一只动物的药量） | ||||||||||
| 给药剂量 | mg/kg |  |
动物平均体重 | g | |
每只动物给药体积 | ul | |
动物数量 | 只 |
| 第二步：请输入动物体内配方组成（配方适用于不溶于水的药物；不同批次药物配方比例不同，请联系GLPBIO为您提供正确的澄清溶液配方） | ||||||||||
| % DMSO % % Tween 80 % saline | ||||||||||
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工作液浓度： mg/ml；
DMSO母液配制方法： mg 药物溶于 μL DMSO溶液（母液浓度 mg/mL，
体内配方配制方法：取 μL DMSO母液，加入 μL PEG300，混匀澄清后加入μL Tween 80，混匀澄清后加入 μL saline，混匀澄清。
1. 首先保证母液是澄清的；
2.
一定要按照顺序依次将溶剂加入，进行下一步操作之前必须保证上一步操作得到的是澄清的溶液，可采用涡旋、超声或水浴加热等物理方法助溶。
3. 以上所有助溶剂都可在 GlpBio 网站选购。
Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial
Haematologica 2019 Jan;104(1):113-119.PMID:30076173DOI:10.3324/haematol.2018.188888.
The randomized, phase III ALFA-0701 trial showed that a reduced and fractionated dose of Gemtuzumab ozogamicin added to standard front-line chemotherapy significantly improves event-free survival (EFS) in adults with de novo acute myeloid leukemia (AML). Here we report an independent review of EFS, final overall survival (OS), and additional safety results from ALFA-0701. Patients (n=271) aged 50-70 years with de novo AML were randomized to receive conventional front-line induction chemotherapy (3+7daunorubicin+cytarabine) with/without Gemtuzumab ozogamicin 3 mg/m2 on days 1, 4, and 7 during induction. Patients in remission following induction therapy received 2 courses of consolidation therapy (daunorubicin+cytarabine) with/without Gemtuzumab ozogamicin (3 mg/m2/day on day 1) according to their initial randomization. The primary end point was investigator-assessed EFS. Secondary end points included OS and safety. A blinded independent review confirmed the investigator-assessed EFS results [August 1, 2011; hazard ratio (HR) 0.66; 95% Confidence Interval (CI): 0.49-0.89; 2-sided P=0.006], corresponding to a 34% reduction in risk of events in the Gemtuzumab ozogamicin versus control arm. Final OS at April 30, 2013 favored Gemtuzumab ozogamicin but was not significant. No differences in early death rate were observed between arms. The main toxicity associated with Gemtuzumab ozogamicin was prolonged thrombocytopenia. Veno-occlusive disease (including after transplant) was observed in 6 patients in the Gemtuzumab ozogamicin arm and 2 in the control arm. In conclusion, Gemtuzumab ozogamicin added to standard intensive chemotherapy has a favorable benefit/risk ratio. These results expand front-line treatment options for adult patients with previously untreated AML. (Trial registered at clinicaltrials.gov; identifier: 00927498).
Addition of Gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia: a meta-analysis of individual patient data from randomised controlled trials
Lancet Oncol 2014 Aug;15(9):986-96.PMID:25008258DOI:10.1016/S1470-2045(14)70281-5.
Background: Gemtuzumab ozogamicin was the first example of antibody-directed chemotherapy in cancer, and was developed for acute myeloid leukaemia. However, randomised trials in which it was combined with standard induction chemotherapy in adults have produced conflicting results. We did a meta-analysis of individual patient data to assess the efficacy of adding Gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia. Methods: We searched PubMed for reports of randomised controlled trials published in any language up to May 1, 2013, that included an assessment of Gemtuzumab ozogamicin given to adults (aged 15 years and older) in conjunction with the first course of intensive induction chemotherapy for acute myeloid leukaemia (excluding acute promyelocytic leukaemia) compared with chemotherapy alone. Published data were supplemented with additional data obtained by contacting individual trialists. The primary endpoint of interest was overall survival. We used standard meta-analytic techniques, with an assumption-free (or fixed-effect) method. We also did exploratory stratified analyses to investigate whether any baseline features predicted a greater or lesser benefit from Gemtuzumab ozogamicin. Findings: We obtained data from five randomised controlled trials (3325 patients); all trials were centrally randomised and open label, with overall survival as the primary endpoint. The addition of Gemtuzumab ozogamicin did not increase the proportion of patients achieving complete remission with or without complete peripheral count recovery (odds ratio [OR] 0·91, 95% CI 0·77-1·07; p=0·3). However, the addition of Gemtuzumab ozogamicin significantly reduced the risk of relapse (OR 0·81, 0·73-0·90; p=0·0001), and improved overall survival at 5 years (OR 0·90, 0·82-0·98; p=0·01). At 6 years, the absolute survival benefit was especially apparent in patients with favourable cytogenetic characteristics (20·7%; OR 0·47, 0·31-0·73; p=0·0006), but was also seen in those with intermediate characteristics (5·7%; OR 0·84, 0·75-0·95; p=0·005). Patients with adverse cytogenetic characteristics did not benefit (2·2%; OR 0·99, 0·83-1·18; p=0·9). Doses of 3 mg/m(2) were associated with fewer early deaths than doses of 6 mg/m(2), with equal efficacy. Interpretation: Gemtuzumab ozogamicin can be safely added to conventional induction therapy and provides a significant survival benefit for patients without adverse cytogenetic characteristics. These data suggest that the use of Gemtuzumab ozogamicin should be reassessed and its licence status might need to be reviewed. Funding: None.
Gemtuzumab ozogamicin: Back Again
J Adv Pract Oncol 2019 Jan-Feb;10(1):68-82.PMID:31308990doi
Despite the recent onslaught of approved medications in oncology, acute myeloid leukemia (AML) has been a disease state bereft of pharmaceutical development for decades. The long-standing first-line regimen, 7 + 3, was developed in 1973. A group of four physicians at Roswell Park Memorial Institute built upon prior combinations of daunorubicin and cytarabine to find the optimal combination of 7 days of cytarabine and 3 days of daunorubicin (Lichtman, 2013). This regimen has undergone multiple modifications and patient performance status-based stratifications, but has remained the first-line therapy for AML for the past 45 years. In September 2017, Gemtuzumab ozogamicin returned to market and shortly thereafter was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for AML, to be administered in combination with 7 + 3, and as monotherapy for both newly diagnosed and relapsed patients with acute myeloid leukemia (NCCN, 2018; US Food & Drug Administration, 2017). Gemtuzumab ozogamicin continues to be explored in various leukemia settings and is a welcomed addition to the currently available treatment options for AML.
Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia
Expert Rev Clin Pharmacol 2018 Jun;11(6):549-559.PMID:29787320DOI:10.1080/17512433.2018.1478725.
Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin. Despite the known clinical efficacy in relapsed/refractory acute myeloid leukemia (AML), GO was withdrawn from the market in 2010 due to increased early deaths witnessed in newly diagnosed AML patients receiving GO + intensive chemotherapy. In 2017, new data on the clinical efficacy and safety of GO administered on a fractionated-dosing schedule led to re-approval for newly diagnosed and relapsed/refractory AML. Areas covered: Addition of fractionated GO to chemotherapy significantly improved event-free survival of newly diagnosed AML patients with favorable and intermediate cytogenetic-risk disease. GO monotherapy also prolonged survival in newly diagnosed unfit patients and relapse-free survival in relapsed/refractory AML. This new dosing schedule was associated with decreased incidence of hepatotoxicity, veno-occlusive disease, and early mortality. Expert commentary: GO represents the first drug-antibody conjugate approved (twice) in the United States for AML. Its re-emergence adds a valuable agent back into the armamentarium for AML. The approval of GO as well as three other agents for AML in 2017 highlights the need for rapid cytogenetic and molecular characterization of AML and incorporation into new treatment algorithms.
Gemtuzumab ozogamicin
Drugs 2001;61(9):1317-22; discussion 1323-4.PMID:11511025DOI:10.2165/00003495-200161090-00007.
Gemtuzumab ozogamicin is a humanised monoclonal IgG4 antibody, linked to a cytotoxic calicheamicin derivative. It effects cell necrosis by specifically targeting the CD33 antigen which is expressed on the surface of leukaemic cell blasts in more than 90% of patients with acute myeloid leukaemia (AML), but is not present on normal stem cells. Therapy with Gemtuzumab ozogamicin (2 doses of 9 mg/m2) in 3 noncomparative studies produced complete remission in 16% of adult patients with AML in first relapse, and complete remission with incomplete platelet recovery in an additional 13% of patients. Rates of remission did not differ between those aged less than 60 years and older than 60 years. Many patients were able to receive both doses of Gemtuzumab ozogamicin therapy as outpatients. Survival duration was similar between those treated as outpatients and those requiring hospitalisation. About one-third of 11 children and adolescents treated with 2 doses of 9 mg/m2 Gemtuzumab ozogamicin in a phase I study showed <5% bone marrow blasts after completion of therapy. The most commonly encountered adverse events in clinical trials with Gemtuzumab ozogamicin were myelosuppression, increased levels of hepatic enzymes, infection, fever, bleeding, chills, nausea and vomiting and dyspnoea. No treatment-related renal failure or alopecia was reported.