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1、DRUGREPORT:bendamustine.SUMMARY.DrugNamebendamustineCompanyJenapharmGmbH&CoKG(BayerAG)HighestDevLaunchedStatusFDAApprovedNon-Hodgkin'sLymphoma,IndolentB-Cell,RefractoryToRituximabOrRituximab-ContainingRegimens(Adult),ChronicLymphoidLeukemia(Adult)TherapyAreasMyelodysplasticsyndr
2、ome;Hodgkinsdisease;Acutelymphoblasticleukemia;Acutemyelogenousleukemia;Chroniclymphocyticleukemia;Chronicmyelocyticleukemia;Mantlecelllymphoma;Plasmacytoma;Multiplemyeloma;B-celllymphoma;Non-Hodgkinlymphoma;BreasttumorActionsAnticancer;Anticancerantimetabolite;PARPmodulator;Alk
3、ylatingagentTechnologiesIntravenousformulation;Infusion;SmallmoleculetherapeuticTargetPARPUpdatedate28-DEC-2010ReasonforSalesandMarketshareUpdatedupdate.OVERVIEW.DevelopedandlaunchedbyJenapharm,andnowmarketedbyCephalon,bendamustine(Treanda;Cytostasan;Ribomustin;Symbenda;Levact;I
4、nnomustine;Treakisym;SDX-105;SyBL-0501)isanalkylatingagentandPARPmodulator.TheproductisindicatedfortheivtreatmentofHodgkin'sdisease,indolentB-cellnon-Hodgkin'slymphoma(NHL)thathasprogressedwithinsixmonthsoftreatmentwithrituximab,plasmacytoma,chroniclymphocyticleukemia(CLL),multi
5、plemyeloma(MM)andbreastcancer[507159],[1053776],[1128224];inJapanitisindicatedforNHLandmantlecelllymphoma(MCL)[1142527]..BendamustineisalsobeingdevelopedoutsideofGermanybyEUlicenseeMundipharma,AsianlicenseesSymBioPharmaceuticals(andasInno-P08001bysublicenseeInnoPharmax)andEisai,
6、andNorthAmericanandAustralianlicenseeSalmedix(nowCephalon),whichalllicensedthedrugfromAstellas,forthepotentialtreatmentofmultiplemyeloma(MM)..From1971to1992,bendamustinewasmarketedinGermanyunderthetradenameCytostasan;howeversince1993,ithasbeenmarketedinGermanybyRibosepharm(subse
7、quentlyacquiredbyKlingePharma,originallyapartofFujisawaDeutschland,nowAstellasPharmaGmbH),underthetradenameRibomustin[507159].TheFDAapprovedbendamustine(asTreanda)forCLLinMarch2008,andUSlicenseeCephalonlaunchedthedrugintheUSinApril2008[888407],[929302].InOctober2008,theFDAadditi
8、onallyapprovedbendamustineforthetreatmentofseco
