| 词条 | Teprotumumab |
| 释义 |
| Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 470602132 | type = mab | image = | alt = | mab_type = mab | source = u | target = IGF-1R | 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_Ref = {{cascite|changed|??}} | CAS_number = 1036734-93-6 | ATC_prefix = none | ATC_suffix = | UNII_Ref = {{fdacite|correct|FDA}} | UNII = Y64GQ0KC0A | PubChem = | DrugBank_Ref = {{drugbankcite|correct|drugbank}} | DrugBank = | ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} | ChemSpiderID = none | KEGG_Ref = {{keggcite|changed|kegg}} | KEGG = D09680 | C=6476 | H=10012 | N=1748 | O=2000 | S=40 | molecular_weight = 145.6 kg/mol }} Teprotumumab (RG-1507) is an experimental human monoclonal antibody developed by Genmab and Roche. It binds to IGF-1R. Teprotumumab was first investigated for the treatment of solid and hematologic tumors, including breast cancer, Hodgkin's and non-Hodgkin's lymphoma, non-small cell lung cancer and sarcoma.[1][2] Although results of phase I and early phase II trials showed promise, research for these indications were discontinued in 2009 by Roche. Phase II trials still in progress were allowed to complete, as the development was halted due to business prioritization rather than safety concerns. Teprotumumab was subsequently licensed to River Vision Development Corporation in 2012 for research in the treatment of ophthalmic conditions. Horizon Pharma acquired RVDC in 2017, and will continue clinical trials.[3] It is in phase II trials for Graves' ophthalmopathy and phase I for diabetic macular edema.[4] It was granted Orphan Drug Status by the FDA for Graves' ophthalmopathy.[5] In a multicenter randomized trial in patients with active Graves' ophthalmopathy Teprotumumab was more effective than placebo in reducing the clinical activity score and proptosis.[6] In February 2019 Horizon Pharma announced results from a Phase 3 confirmatory trial evaluating teprotumumab for the treatment of active thyroid eye disease (TED). The study met its primary endpoint, showing more patients treated with teprotumumab compared with placebo had a meaningful improvement in proptosis, or bulging of the eye: 82.9 percent of teprotumumab patients compared to 9.5 percent of placebo patients achieved the primary endpoint of a 2 mm or more reduction in proptosis (p<0.001). Proptosis is the main cause of morbidity in TED. All secondary endpoints were also met and the safety profile was consistent with the Phase 2 study of teprotumumab in TED.[7] References1. ^https://clinicaltrials.gov/ct2/show/NCT01868997 {{monoclonals for tumors}}{{Growth factor receptor modulators}}{{monoclonal-antibody-stub}}{{antineoplastic-drug-stub}}2. ^http://adisinsight.springer.com/drugs/800015801 3. ^http://www.genmab.com/product-pipeline/products-in-development/teprotumumab 4. ^http://adisinsight.springer.com/drugs/800015801 5. ^http://www.genmab.com/product-pipeline/products-in-development/teprotumumab 6. ^{{cite journal|last1=Smith|first1=TJ|last2=Kahaly|first2=GJ|last3=Ezra|first3=DG|last4=Fleming|first4=JC|last5=Dailey|first5=RA|last6=Tang|first6=RA|last7=Harris|first7=GJ|last8=Antonelli|first8=A|last9=Salvi|first9=M|last10=Goldberg|first10=RA|last11=Gigantelli|first11=JW|last12=Couch|first12=SM|last13=Shriver|first13=EM|last14=Hayek|first14=BR|last15=Hink|first15=EM|last16=Woodward|first16=RM|last17=Gabriel|first17=K|last18=Magni|first18=G|last19=Douglas|first19=RS|title=Teprotumumab for Thyroid-Associated Ophthalmopathy.|journal=The New England Journal of Medicine|date=4 May 2017|volume=376|issue=18|pages=1748–1761|doi=10.1056/NEJMoa1614949|pmid=28467880|pmc=5718164}} 7. ^{{Cite web|url=http://ir.horizon-pharma.com/news-releases/news-release-details/horizon-pharma-plc-announces-phase-3-confirmatory-trial|title=Horizon Pharma plc Announces Phase 3 Confirmatory Trial Evaluating Teprotumumab (OPTIC) for the Treatment of Active Thyroid Eye Disease (TED) Met Primary and All Secondary Endpoints|website=Horizon Pharma plc|language=en|access-date=2019-03-22}} 3 : Hoffmann-La Roche|Experimental cancer drugs|Orphan drugs |
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