Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. The generic name usually includes the active ingredient(s) of the product. Moxetumomab pasudotox is given after at least two other cancer treatments did not work or have stopped working. Moxetumomab pasudotox can damage your kidneys, especially if you already have kidney disease or if you are 65 years of age or older. Moxetumomab pasudotox-tdfk is a CD22 -directed cytotoxin. Moxetumomab pasudotox-tdfk is approved to treat: Hairy cell leukemia that has relapsed or is refractory (does not respond to treatment). The active substance in Lumoxiti, moxetumomab pasudotox, is made up of an antibody (a type of protein) attached to part of a toxin from the Pseudomonas bacteria. A multicenter phase 1 study was conducted to determine the maximum-tolerated cumulative dose (MTCD) and evaluate safety, activity, pharmacokinetics, and immunogenicity of moxetumomab pasudotox in children, adolescents, and young adults with ALL (N = 55). This medicine is to be given only by or under the direct supervision of your doctor. Credit: National Cancer Institute The Food and Drug Administration (FDA) has approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). Moxteumomab is the generic name for the trade name drug Lumoxiti. Moxetumomab pasudotox is a CD22-directed cytotoxin composed of a recombinant murine immunoglobulin genetically fused to truncated Pseudomonas exotoxin (PE38). Moxetumomab pasudotox-tdfk binds CD22 on the cell surface of B-cells and is internalized. Moxetumomab pasudotox (Moxe) binds CD22 receptors on the surface of cancerous B cells, where it is internalized and processed to release its toxic payload. Antileukemic activity has been demonstrated in children with chemotherapy‐refractory B‐cell precursor acute lymphoblastic leukemia (BCP‐ALL), with variable responses. Moxetumomab pasudotox may also be used for purposes not listed in this medication guide. Moxetumomab pasudotox showed durable responses in patients with hairy cell leukemia after 2 or more lines of prior therapy. We hope … Moxetumomab pasudotox-tdfk has an approximate molecular weight of 63 kDa and is produced in E. coli cells by recombinant DNA technology. Moxetumomab pasudotox-tdfk is composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, PE38, that inhibits protein synthesis. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. We were able to administer moxetumomab pasudotox at doses up to 50 μg/kg QOD ×3 without DLT. Objectives: This article describes clinical guidelines for the administration of moxetumomab pasudotox to patients with R/R HCL and presents related case studies. Moxetumomab pasudotox is used to treat adults with hairy cell leukemia. Moxetumomab pasudotox has been approved by the FDA for the treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog. See full prescribing information for complete boxed warning. (mox e TOOM oh mab) Trade Name: Lumoxiti®. Moxetumomab pasudotox-tdfk is composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, which inhibits protein synthesis. Medical. Here, we present the long-term follow-up analysis of the pivotal, multicenter, open-label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL). Kreitman RJ, Dearden C, Zinzani PL, et al. This drug may cause you to swell or keep fluid in your body. Moxetumomab Pasudotox-tdfk (Lumoxiti™) | OncoLink Follow our blog for education, inspiration, and support during the COVID-19 pandemic. Moxetumomab pasudotox-tdfk injection is in a class of medications called monoclonal antibodies. Statistical analysis Rituximab was used as a historical control to determine sample size, as it was the most frequently used non- Here, we present the long‑ term follow‑up analysis of the pivotal, multicenter, open‑label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL). If you are in the US and would like additional information regarding AstraZeneca drugs, please contact the Information Center at … Moxetumomab pasudotox goes through the blood vessels to get into the area surrounding the blood vessels where hairy cells often live. Moxetumomab pasudotox (MP) is an immunotoxin that recently received US Food and Drug Administration (FDA) approval for the treatment of hairy cell leukemia (HCL) that has failed at least 2 prior lines of therapy, including a purine analog.MPis a recombinant immunotoxin that consists of an anti-CD22 immunoglobulin variable domain genetically joined to Pseudomonas exotoxin (PE38). A phase 2 study further evaluated efficacy. More About Moxetumomab Pasudotox-tdfk Toggle navigation. The active substance in Lumoxiti, moxetumomab pasudotox, is made up of an antibody (a type of protein) attached to part of a toxin from the Pseudomonas bacteria. Moxetumomab pasudotox can damage your kidneys, especially if you already have kidney disease or if you are 65 years of age or older. Patients received moxetumomab pasudotox … Results/conclusion: Moxetumomab pasudotox, a novel recombinant anti-CD22 immunotoxin, was well tolerated and active in the previous phase 1 and 3 studies in patients with HCL. Coverage of any drug intervention discussed in a WellFirst Health medical policy is subject to the limitations and exclusions outlined in the member's benefit certificate or policy and applicable state and/or federal laws. Moxetumomab pasudotox-tdfk (LUMOXITI™), an anti CD22 recombinant immunotoxin, has been developed by MedImmune and its parent company AstraZeneca for the treatment of hairy cell leukaemia. Delay dosing Moxetumomab pasudotox can damage your kidneys, especially if you already have kidney disease or if you are 65 years of age or older. Leukemia. : The reason this drug [moxetumomab pasudotox] causes kidney problems, we don’t know exactly, but we feel that there’s something like CD22 in the kidneys that the drug binds to nonspecifically. Left, illustration of the structure of PE, PE38, and recombinant immunotoxin moxetumomab pasudotox designed to kill CD22-expressing cells. Purpose To conduct a phase I dose-escalation trial assessing safety and response of recombinant immunotoxin moxetumomab pasudotox (CAT-8015, HA22) in chemotherapy-resistant hairy cell leukemia (HCL). Avoid moxetumomab pasudotox use in patients who have a history of severe thrombotic microangiopathy (TMA) or hemolytic-uremic syndrome (HUS). 11-Digit NDC Billing Format: 73380470001 NDC Format for Billing Moxetumomab pasudotox is used to treat adults with hairy cell leukemia. Capillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving LUMOXITI. REF-34765, AstraZeneca Pharmaceuticals LP. Moxetumomab pasudotox was administered at 40 µg/kg intravenously on days 1, 3, and 5 of each 28-day cycle. Your doctor will decide how many treatment cycles you need. Abstract. It is used to treat hairy-cell leukemia. Importance of Hydration With Moxetumomab Pasudotox. Get emergency medical help if you have: unusual bruising or bleeding, fever, confusion, tiredness or irritability, stomach pain, vomiting, dark urine, fast … The drug has been approved in 2018 by the FDA for the treatment of patients with relapsed/refractory HCL who had at least two prior systemic therapies including at least one purine nucleoside analog. This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a … REF-34765, AstraZeneca Pharmaceuticals LP. moxetumomab pasudotox, and safety was evaluated in the safety population, which comprised all patients who received at least one dose of moxetumomab pasudotox; both populations comprise the same 80 patients. Background: Moxetumomab pasudotox is a recombinant CD22‑targeting immunotoxin. Some side effects may occur during the injection. Moxetumomab pasudotox-tdfk (Lumoxiti) is a CD22-directed cytotoxin that was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of relapsed or refractory HCL. The Fv portion of moxetumomab pasudotox binds to CD22, a cell surface receptor expressed on a variety of malignant B-cells, thereby delivering the toxin moiety PE38 directly to tumor cells. Repeated dosing, despite early neutralizing antibodies, increased … Moxetumomab pasudotox-tdfk is composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, which inhibits protein synthesis. Get emergency medical help if you have: unusual bruising or bleeding, fever, confusion, tiredness or irritability, stomach pain, vomiting, dark urine, fast … title = "Moxetumomab pasudotox: Anti-CD22 immunotoxin oncolytic", abstract = "The development of recombinant immunotoxins as an alternative to conventional chemotherapy is promising, especially for the treatment of hematological malignancies. Moxetumomab pasudotox-tdfk injection is in a class of medications called monoclonal antibodies. Intoxication of cells by moxetumomab pasudotox. Moxetumomab pasudotox – Medicines – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice. In some cases, health care professionals may use the trade name Lumoxiti when referring to the generic drug name moxetumomab. Lumoxiti (Moxetumomab pasudotox –tdfk) for the Treatment of Hairy Cell Leukaemia. Tell your doctor if you have swelling, weight gain, or trouble breathing. MOXETUMOMAB PASUDOTOX is a monoclonal antibody and a chemotherapy drug. Severe HUS has been reported with moxetumomab use; most cases occur within 9 days (range, 1 … The MMAE is targeted to certain cancers by immunerecognition and delivered into cancer cells via receptor mediated endocytosis. Moxetumomab pasudotox-tdfk injection is used to treat hairy cell leukemia (cancer of a certain type of white blood cell) that has returned or has not responded after at least two other cancer treatments. It is used in adults who have been treated with at least two systemic therapies, including a purine nucleoside analog. It is an immunotoxin, which is a substance that consists of an antibody bound to a toxic substance. Moxetumomab pasudotox is an anti-CD22 recombinant immunotoxin in development for the treatment of r/r CD22+ lymphoid malignancies. moxetumomab pasudotox是由阿斯利康开发的一种首创的抗CD22重组免疫毒素，也是阿斯利康抗体-药物偶联物平台中首个即将进入监管审查的产品，有望为复发性或难治性HCL患者群体带来一种创 … Moxetumomab pasudotox (MP) is an immunotoxin that recently received US Food and Drug Administration (FDA) approval for the treatment of hairy cell leukemia (HCL) that has failed at least 2 prior lines of therapy, including a purine analog. LUMOXITI™ (moxetumomab pasudotox-tdfk) for injection, for intravenous use Initial U.S. Approval: 2018 . Lumoxiti (moxetumomab pasudotox, formerly CAT8015 or HA22) is a CD22-directed cytotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. moxetumomab pasudotox Single-dose vials: 1 mg 00310-4700-01 J9313 . International audienceThis is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. Moxetumomab pasudotox is used to treat adults with hairy cell leukemia. Moxetumomab pasudotox is given after at least two other cancer treatments did not work or have stopped working. Moxetumomab pasudotox (formerly CAT-8015 or HA22) is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine with the opportunity to be a first-in-class treatment in the US for patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. “Moxetumomab pasudotox is a non-chemotherapeutic agent that has the potential to become a standard of care for patients with relapsed/refractory HCL,” Dr. Kreitman, of the National Cancer Institute’s Center for Cancer Research, said during his presentation of the … Once internalized, PE38 induces caspase-mediated apoptosis via a mechanism involving mitochondrial damage and blocks translational elongation by binding to elongation factor 2 (EF-2). Compare CD22 antibodies. Kreitman RJ, Dearden C, Zinzani PL, et al. Anti-CD22 (Moxetumomab pasudotox)-MC-Vc-PAB-MMAE ADC (ADC-W-803) This ADC product is comprised of an anti-CD22 monoclonal antibody conjugated via a MC-Vc linker to MMAE. Right, cartoon showing the steps required for the entry and cell killing by moxetumomab pasudotox and similar recombinant immunotoxins containing PE38. Moxetumomab pasudotox-tdfk injection is used to treat hairy cell leukemia that has worsened or cannot be completely removed in patients who have had at least two previous treatments that did not work well. It works by binding CD22 on the surface of B-cells and is internalized, which Moxetumomab pasudotox binds CD22 on the cell surface of B-cells and is internalized. Overall, 50 patients completed a full 6 cycles of treatment (62.5%), with patients most commonly discontinuing due to CR with minimal residual disease (MRD) negativity (15%) and adverse events (15%). It works by binding CD22 on the surface of B-cells and is internalized, which Moxetumomab pasudotox may also be used for purposes not listed in this medication guide. Moxetumomab pasudotox (MP) is an immunotoxin that recently received US Food and Drug Administration (FDA) approval for the treatment of hairy cell leukemia (HCL) that has failed at least 2 prior lines of therapy, including a purine analog. Moxetumomab pasudotox is an anti-CD22 immunotoxin designed for the treatment of cancer. “Moxetumomab pasudotox is a nonchemotherapeutic agent that has the potential to become a standard of care for patients with relapsed/refractory HCL,” Dr. Kreitman, of the National Cancer Institute’s Center for Cancer Research, said during his presentation of the results at the 2018 ASCO Annual Meeting. Moxetumomab pasudotox can damage your kidneys, especially if you already have kidney disease or if you are 65 years of age or older. It binds CD22 on the cell surface of B-cells and is internalized. The antibody in this medicine has been designed to recognise and attach to an antigen (target) called CD22, which is found on the surface of B cells in hairy cell leukaemia. Moxetumomab pasudotox is a second‐generation recombinant immunotoxin against CD22 on B‐cell lineages. Patients and Methods Eligible patients had relapsed/refractory HCL after ≥ two prior therapies and required treatment because of abnormal blood counts. Get emergency medical help if you have: unusual bruising or bleeding, fever, confusion, tiredness or irritability, stomach pain, vomiting, dark urine, fast heartbeats, and … Pregnant women are excluded from this study because moxetumomab pasudotox-tdfk and rituximab are agents with the potential for teratogenic or abortifacient effects. Find prescribing information for LUMOXITI™ (moxetumomab pasudotox-tdfk) from AstraZeneca. In Study 1053, patients with ADA titres >10 240 showed ~4‐fold increase in CL. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Tell your caregiver if you feel dizzy, nauseated, hot or cold, light-headed, or have a headache, muscle pain, cough, trouble breathing, or fast heartbeats. Moxetumomab Pasudotox What is the Non-Proprietary Name? It is made up of an antibody (a type of protein) attached to part of a toxin from the Pseudomonas bacteria. Biologic Drug: Biologic drugs are made from living cells and are often expensive. Moxetumomab pasudotox-tdfk is composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, which inhibits protein synthesis. moxetumomab pasudotox是由阿斯利康开发的一种首创的抗CD22重组免疫毒素，也是阿斯利康抗体-药物偶联物平台中首个即将进入监管审查的产品，有望为复发性或难治性HCL患者群体带来一种创新的治疗选择。 This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated GFR of 30-59 ml/min. Moxetumomab Pasudotox-tdfk. Moxetumomab Pasudotox What is the Non-Proprietary Name?
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