Microsoft Word - FINAL２ CheckMate 066 Filing Acceptance Release 042915.docx


U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for

Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma

Application includes CheckMate -066, a clinical trial of Opdivo vs. dacarbazine chemotherapy in patients who had not received prior therapy

CheckMate -066 marked the first time that a PD-1 immune checkpoint inhibitor demonstrated

survival in a Phase III clinical trial

(PRINCETONN, JA, pri2l92,015) - Bristol-MyerSsquibCbompany (NYSEB: MYt)oday announcedthatthUe .SF.oodanDd rugAdministration(FDAh)ascceptedfofrilinganrdeviewthe

supplementaBl iologicLs icensAe pplication(sBLAf)or Opdivo (nivolumab) fotrhtereatmenotf previousluyntreatedpatientws ithunresectabloemr etastatimc elanomaT. hFeDAalsograntedPriority ReviewfotrhiaspplicationT. hperojectedFDAactiondatieAs ugus2t72,015.

Opdivo wafsirsatpprovedbythFeDAinDecembe2r014fopratientws ithunresectabloer

metastatimc elanomandiseasperogressionfollowing Yervoy (ipilimumaba)ndiB,f RAFV600 mutatiopnositiveBa, RAFinhibitorT. hiisnitial indicatiown aspprovedundearcceleratedapproval basedontumorresponsreataendu rabilitoyrfesponsferomCheckMat-e037clinicatlriarlesultsT. his
newsBLA acceptedbtyhFeDAincludedsatfaromCheckMat-e066w, hichevaluated Opdivoin
treatmenntaïvpeatientws ithBRAFwild-typaedvancedmelanomacsomparedtdo
acarbazine
chemotherap(yDTIC)I.nthterials,afetyandtolera bilitywerwe ell-characti zewd ithfewetreatment- relateGd rad3e/a4dverse eventosbse rvedwith Opdivothandacarbazine.
"ThCe heckMat-e06t6riaml ark etdhfeirsttimtehaPatD-i1mmunceheckpoinitnhibitor showesdaurvivablenefiitrnaandomizedPhasIeItIrial,s"aidMichaeGl iordanos,eniovricperesident, HeadoDf evelopmentO, ncologyB, ristol-MyerSsquibb".Wleookforwardtocontinuingtoworwk ith thFeDAtoensurceancepratientasrperovidedthleatesctlinicaaldvancetshahtavtehpeotentiaflor improvedresponseasnldong-termsurvival."

About Advanced Melanoma

Melanomiafasormosfkincancecrharacterizedbythuencontrolledgrowthopfigment- producingcell(smelanocytesl)ocateditnhsekinM. e tastatimc elanomiatshdeeadliesftormotfhe diseasea,ndoccurws hencancesrpreadbseyondthseurfacoetfhsekintothoetheorrganss,uchatshe
lympnh
odesl,ungsb,raionorthearreaostfhbeodyT. hiencidencoemf elanomhaabseeinncreasinfgor
alteas3t0yearsI.n2015a,nestimated73,870melanomcaasews ilbldeiagnosedinthUe .SM. elanoma
ims ostlycurablwe hentreatedinitesarlystagesH. owe veri,nitlsatsetagest,h
jus6mt onthws it1ha-yeasrurvivaol2f5.5%m, akingiotnoetfhme osatggressivfeormoscfancer.
aeveragseurvivarlaties

About Opdivo

Opdivoipasrogrammedeath-(1PD-1i)mmunceheckpoinitnhibitotrhahtarseceivedapproval

fromthUe .SF.DAamas onotherapiytnwcoanceirndicationsO. Mn arc5h2,015, Opdivoreceived
FDAapprovaflotrhtereatmenotpfatientws ith metastatiscquamounson-smalclellluncgancer
(NSCLCw) ithprogressionoonarfteprlatinum-basedchemotherapy.
ItnhUe .S., Opdivoiaslsoindicatefdotrhtereatmenotpfa tientws ithunresectabloemr etastatic melanomandiseasperogressionfollowing Yervo(yipilimumaba)ndiB,f RAFV600mutationpositive, Ba RAFinhibitorT. hiisndicatioiaspprovedundearcceleratedapprovablaseodntumorresponsreate andurabilityorfesponseC. ontinuedapprovaflotrh iisndicationmaybceontingenutpovnerification andescriptiooncflinicablenefiitnthceonfirmatorytrials. OpdivobecamtehfeirsPtD-i1mmune checkpoinitnhibitotrroeceivreegulatoryapprov alnywherietnhwe orldoJnuly42,014whenOno PharmaceuticaCl oa.nnouncedthairteceivedmanufacturingandmarketingapprovailnJapanfotrhe
treatmenotpfatientws ith unresectablme elanoma.
Bristol-MyerSsquibhbabasroadg,lobadlevelopmenptrogramtostudy Opdivoinmultiple
tumotrypecsonsistingomf ortehan50trial-asms onotherapoyirncombinatiown
ithothetrherapie-s
iwn
hichmortehan7,00patienthsavbeeenenrolledworldwide.

Immuno-Oncology at Bristol-Myers Squibb

Surgeryr,adiationc,ytotoxioctrargetedtherapiehsavreepresentedthme ainstaoycfancer
treatmenotvetrhleassteveradle cadesb,ultong-termsurvivaalnd remainedelusivfeomr anypatientws itahdvancedisease.
paositivqeualitoylfifheave
Toaddrestshiusnmemt edicanleedB, ristol-Myers Squibbilseadingresearchinaninnovative fielodcfancerresearchandtreatmenktnownaismmuno-oncologyw, hicihnvolveasgentws hose primarymechanismitsoworkdirectlywiththbeody'ismmunseystemtofighctancerT. hceompanyis explorinvgaarietoycfompoundasndimmunotherapeutiacpproachefsopratientws itdifferenttypeosf canceri,ncludinrgesearchingthpeotentiaolcfombininigmmuno-oncologyagenttshattargedtifferent
pathwayistnhtereatmenotcfancer.
Bristol-MyerSsquibbicsommittedtoadvancintgh
seciencoeifmmuno-oncologyw, iththgeoal
ocfhangingsurvivaelxpectationasnd thwe apyatientlsivwe ithcancer.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

I2n011t,hrougchaollaboratioangreemenwt i thOnoPharmaceuticalB, ristol-MyerSsquibb
expandedittserritoriarlighttsdoevelopancd
ommercialize Opdivo globallyexcepitJnapanS,outh
KoreandTaiwanw, herOe nohadretainedalrlights tothceompoundatthteimeO. nJuly232,014, Bristol-MyerSsquibbandOnoPharmaceuticaflurtheerxpandedthceompaniess'trategicollaboration agreementtojointlydevelopandcommercializme ultipliemmunotherapie-asssinglaegentasnd
combinatiornegimenf-sopratientws ithcanceirJnapanS,outKh oreandTaiwan.

IMPORTANT SAFETY INFORMATION Immune-Mediated Pneumonitis

Severpeneumonitiosirnterstitiallundgisease,

includingfataclaseso,ccurredwithOPDIVO

treatmentA. crostshcelinicatlriaelxperiencien

691patientws itsholidtumorsf,atailmmune-

mediatedpneumonitiosccurredi0n.7%(5/691o)pfatientrseceivingOPDIVOn;ocases
occurrediTn ria1lI.nTria1lp,neumonitisi,ncl udinginterstitiallundgiseaseo,ccurredi3n.4% (9/268o)pfatientrseceivingOPDIVOanndonoetfh1e0p2atientrseceivingchemotherapy.
Immune-mediatepdneumonitios
ccurredin2.2%(6 /268o)pfatients receivinOg PDIVOo;ne
witGh rad3aendfivwe ithGrad2eM. onitor patientfsosrignasndsymptomospfneumonitis. AdministecrorticosteroidfsoGr rad2oer greateprneumonitisP.e rmanentldyiscontinue OPDIVOfoGr rado3e4arnwd ithhold OPDIVOuntirlesolutionfoGr rad2e.

Immune-Mediated Colitis

 InTria1ld,iarrheoacrolitiosccurreidn21%(57/268o)pfatientrseceivingOPDIVOand18% (18/102o)pfatientrseceivingchemotherapyI.m mune-mediatedcolitiosccurredi2n.2%(6/268) opfatientrseceivinOPDIVOf;ivwe itGrad3aenodnwe ithGrad2eM. onitopratientfsor
immune-mediatecdolitisA. dministecrorticostero idfsoGr rad2(eomf ortehan5daydsuration),
3o,4crolitisW.
ithholdOPDIVOfoGr rad2oe3rP.ermanentlydiscontinuOe PDIVOfoGr rade
4colitiosrecurrenctolitiusponrestartingOPDIVO.

Immune-Mediated Hepatitis

 InTria1lt,herwe aasinncreasedincidencoef livetresatbnormalitie
istnhOe PDIVO-treated
groupacsomparedtothcehemotherapy-treategdroupw, ithincreaseisnAST(28%v1s2%), alkalinpehosphatas(e22%v1s3%)A, LT(16%v5s%)a,ntdotablilirubin(9%v0s)I.mmune- mediatedhepatitiosccurredin1.1%(3/268o)f patientrseceivingOPDIVOt;wwo itGh rad3e anodnwe ithGrad2eM. onitopratientfsoarbno rmallivetrestpsriotraondperiodicalldyuring
treatmentA. dministecrorticosteroidfsoGr rad2oegrreatetrransaminaselevationsW.
ithhold
OPDIVOfoGr rad2aenpermanentlydiscontinuOe PDIVOfoGr rado3ei4rmmune-mediated hepatitis.

Immune-Mediated Nephritis and Renal Dysfunction

 InTria1lt,herwe aasinncreasedincidencoeeflevatedcreatininietnhOe PDIVO-treategdroup acsomparedtthcehemotherapy-treategdrou(p13%v9s%)G. rado2e3irmmune-mediated nephritiosrrenadlysfunctiooccurreidn0.7%(2/268o)pfatientsM. onitopratientfsoerlevated serumcreatininperiotroanpderiodicallydurintgreatmentF.oGr rado2es3rerumcreatinine elevationw, ithholdOPDIVOanaddministecrorticosteroidsiw;f orseningonroimprovement occursp,ermanentldyiscontinuOe PDIVOA. dministecrorticosteroidfsoGr rad4se rum creatininelevationandpermanentlydiscontinuOe PDIVO.

Immune-Mediated Hypothyroidism and Hyperthyroidism

 InTria1lG, rad1oe2hrypothyroidismoccurredi8%(21/268o)pfatientrseceivinOg PDIVO
anndonoetfh1e02patientrseceivingchemotherapyG. rad1oe2hryperthyroidismoccurredin
3%(8/268o)pfatientrseceivingOPDIVOand1%(1/102o)pfatientrseceivingchemotherapy. MonitotrhyroidfunctiopnriotroandperiodicalldyuringtreatmentA. dministehrormone replacementtherapyfohrypo thyroidismI.nitiatme edicaml anagemenftocrontroolf hyperthyroidism.

Other Immune-Mediated Adverse Reactions

Thfeollowingclinicallysignificanti,mmune-med

iatedadversreeactionosccurredinlestshan

2%oOf PDIVO-treatedpatientsa:drenailnsuffic

iencyu,veitisp,ancreatiti sf,aciaalnadbducens

nervpearesisd,emyelinationa,utoimmune uropathym, otodrysfunctiona,nvdasculitisA. cross
clinicatlrialosOf PDIVOadministeredadto se3ms g/kagnd10mg/kga,dditionacllinically significanti,mmune-mediateaddversreeacti onws eriedentifiedh:ypophysitisd,iabetic ketoacidosish,ypopituitarismG, uillain-Barrséy ndromea,nmd yastheniscyndromBea. seodn thseeverityoafdversreactionw, ithholOd PDIVOa,dministehrigh-dosceorticosteroidsa,ndi,f
appropriatei,nitiatheormone

Embryofetal Toxicity

r-eplacementtherapy.
 Basedonitms echanismoafctionO, PDIVOcancausfeetahlarmwhenadministeredtoa pregnanwt omanA. dvisperegnanwt omeontfhpeotentiarlisktfoaetusA. dvisfeemaleosf reproductivpeotentiatlouseffectivceontrace ptiodnuringtreatmenwt itOh PDIVOandfoart leas5mt onthasftetrhleasdtosoeOf PDIVO.

Lactation

 IintsoktnownwhetheOr PDIVOipsresenitnhumanmilkB. ecausme anydrugsi,ncluding antibodiesa,rexcretedinhumanmilkandbecausoetfhpeotentiaflosreriouasdversreeactions
inursinginfantfsromOPDIVOa,
dviswe omentodiscontinuberea stfeedindguringtreatment.

Serious Adverse Reactions

 Seriouasdversreeactionosccurredin41%opfatientrseceivinOg PDIVOG. rad3aend4adverse reactionosccurreidn42%opfatientrseceivinOPDIVOT. hme osftrequenGt rada3en4d adversderugreactionrseportedin2%to

Common Adverse Reactions

 Thme osctommonadversreaction( ≥20%r)eportedwithOPDIVOwarsash(21%).

Please see US Full Prescribing Informationfor OPDIVO.

About Bristol-Myers Squibb

Bristol-MyerSsquibbigaslobaplharmaceuticaclompanywhosme issionitsodiscoverd,evelopand deliveirnnovativme edicinetshahtelpatientpsreva iolvesrerioudsiseasesF.omr orienformationabout
Bristol-MyerSsquibbv,isit www.bms.como,frollowuosnTwitteart http://twitter.com/bmsnews

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval for this new indication or, if approved, that it will become a

commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current

Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events or otherwise.

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Contacts: MediaC: hrissyTrank6,09-419-5497, christina.trank@bms.com Investors: RanyDa ajani6,09-252-5330, ranya.dajani@bms.com
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