ReviewReport

July18,2018

PharmaceuticalsandMedicalDevicesAgency

Thefollowingaretheresultsofthereviewofthefollowingpharmaceuticalproductsubmittedformarketing

approvalconductedbythePharmaceuticalsandMedicalDevicesAgency(PMDA).

BrandNamePoteligeoInjection20mg

Non-proprietaryNameMogamulizumab(GeneticalRecombination)(JAN*)

ApplicantKyowaHakkoKirinCo.,Ltd.

DateofApplicationNovember30,2017

DosageForm/StrengthSolutionforinjectioncontaining20mgofmogamulizumab(genetical

recombination)pervial(5mL)

ApplicationClassificationPrescriptiondrug,(4)Drugwithanewindication(6)Drugwithanewdosage

ItemsWarrantingSpecialMentionOrphandrug(DrugDesignationNo.298of2013[25yaku],

PSEHB/PEDNotificationNo.0315-2datedMarch15,2013,bythePharmaceutical

EvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau,Ministry

ofHealth,LabourandWelfare)

ReviewingOfficeOfficeofNewDrugV

ResultsofReview

Onthebasisofthedatasubmitted,PMDAhasconcludedtheproducthasefficacyinthetreatmentofrelapsed

orrefractorycutaneousT-celllymphomaandthattheproducthasacceptablesafetyinviewofitsbenefits(see

Attachment).

Asaresultofitsreview,PMDAhasconcludedthattheproductmaybeapprovedfortheindicationsanddosage

andadministration,withthefollowingcondition.

Indications

CCR4-positiveadultT-cellleukemialymphoma

RelapsedorrefractoryCCR