| 词条 | Isatuximab |
| 释义 |
| type = mab | image = | alt = | mab_type = mab | source = xi/o | target = CD38 | tradename = | Drugs.com = | MedlinePlus = | pregnancy_AU = | pregnancy_US = | pregnancy_category= | legal_AU = | legal_CA = | legal_UK = | legal_US = | legal_status = | routes_of_administration = | bioavailability = | protein_bound = | metabolism = | elimination_half-life = | excretion = | CAS_number = 1461640-62-9 | ATC_prefix = none | ATC_suffix = | UNII_Ref = {{fdacite|correct|FDA}} | UNII = R30772KCU0 | KEGG = D11050 | PubChem = | DrugBank = | ChemSpiderID = none | C=6456 | H=9932 | N=1700 | O=2026 | S=44 | molecular_weight = 145.2 kg/mol | synonyms = SAR-650984 }}Isatuximab is a monoclonal antibody (mAb) designed for the treatment of cancer.[1] It was developed by ImmunoGen and Sanofi-Aventis with the development name SAR-650984. It was given orphan drug status for multiple myeloma by the FDA in December 2016.[2] Isatuximab is an anti-CD38 mAb intended to treat relapsed or refractory multiple myeloma.[3] {{as of|2015}}, it is in phase II trials for multiple myeloma[4] and T-cell leukemia.[5] A phase III combination trial for plasma cell myeloma is comparing pomalidomide and dexamethasone with and without isatuximab is in progress with an estimated completion date of 2021.[6] Two additional phase III trials were launched in 2017. The first trial is assessing the benefit of isatuximab in combination with bortezomib, lenalidomide and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma not eligible for transplant (IMROZ trial). The second trial is assessing the benefit of isatuximab combined with carfilzomib and dexamethasone versus carfilzomib with dexamethasone in patients with relapse and/or refractory multiple myeloma previously treated with 1 to 3 prior lines (IKEMA). See also
References1. ^Statement On A Nonproprietary Name Adopted By The USAN Council - Isatuximab, American Medical Association. {{monoclonals for tumors}}{{antineoplastic-drug-stub}}{{monoclonal-antibody-stub}}2. ^http://adisinsight.springer.com/drugs/800029577 3. ^ImmunoGen, Inc. Announces Data Presentations at Upcoming 57th ASH Annual Meeting and Exposition 4. ^{{cite journal |title=A Dose Finding Phase II Trial of Isatuximab (SAR650984, Anti-CD38 mAb) As a Single Agent in Relapsed/Refractory Multiple Myeloma |last1=Martin |first1=Th |journal=Blood |year=2015 |volume=126 |issue=23 |page=509 |url=http://www.bloodjournal.org/content/126/23/509?sso-checked=true}} 5. ^{{ClinicalTrialsGov|NCT02999633|Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia}} 6. ^{{ClinicalTrialsGov|NCT02990338|Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients (ICARIA-MM)}} 3 : Monoclonal antibodies|Experimental cancer drugs|Orphan drugs |
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