Docket No.: ('( iR50() l USCNT l
`
`I hereby certify that this correspondence is being transmitted via The Officefl
`Electmnic Filing System (T-IFS) in accordance with 37 (‘FR l.6(n)(4).
`
`Date of Electronic (EFS) Transmission:
`
`June 4, 2013
`
`Signature: /Laurie A. Phillips/’ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`Apfi1i¢‘;n{(s5§ A
`
`"f"X155‘ii‘j’;&£e;i;a;3i§“’""‘"“
`
`:Title:
`
`\
`'
`i
`Examiner:
`: Methods and Compositions for Treating Cancer
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`RESPONSE
`
`In response to the final Office Action mailed March 4, 2013, Applicant submits
`
`the following amendments and remarks.
`
`A list of the Claims are reflected in the listing of claims, which begins on page 2
`
`of this paper.
`
`Remarks/Arguments begin on page 4 of this paper.
`
`Page 1 of9
`
`JANSSEN EXHIBIT 2167
`
`Wockhardt v. Janssen lPR2016-01582
`
`JANSSEN EXHIBIT 2167
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`Docket No.: C(}R500l USCNTI
`
`Listing of Claims:
`
`l—36. (Canceled).
`
`37‘ (Previously presented) A method for the treatment of a prostate cancer in a human
`
`comprising administering to said human a therapeutically effective amount of abiraterone
`
`acetate or a pharmaeeutically acceptable salt
`
`thereof and a therapeutically effective
`
`amount of prednisone.
`
`38. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the abiraterone acetate or pharmaeeutically acceptable salt thereof is from
`
`about 50 mg/day to about 2000 mg/day.
`
`39. (Previously presented) The method ofelairn 38, wherein the therapeutically effective
`
`amount of the abiratcrone acetate or pharmaeeutieally acceptable salt thereof is from
`
`about 500 mg/day to about 1500 mg/day.
`
`40. (Previously presented) The method of claim 39, wherein the therapeutically effective
`
`amount of the abiraterone acetate or pharmaceutieally acceptable salt thereof is about
`
`l000 mg/day.
`
`Page 2 of 9
`
`

`

`Docket No.: CGRSOOIUSCNTI
`
`41. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the abiraterone acetate or a pharmaceutically acceptable salt
`
`thereof is
`
`administered in at least one dosage form comprising about 250 mg of abiraterone acetate
`
`or a pharmaceutically acceptable salt thereof.
`
`42. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the prednisone is from about 0.01 mg/day to about 500 mg/day.
`
`43. (Previously presented) The method of claim 42. wherein the therapeutically effective
`
`amount ofthc prednisone is from about l0 mg/day to about 250 mg/day.
`
`44. (Previously presented) The method of claim 44, wherein the therapeutically effective
`
`amount of the prednisone is about 10 mg/day.
`
`45. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the prednisone is administered in at least one dosage form comprising about 5
`
`mg of prednisone.
`
`46. (Previously presented) The method of claim 37, comprising administering to said
`
`human about 500 mg/day to about
`
`1500 mg/day of abiratcrone acetate or
`
`a
`
`pharmaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of
`
`prednisone.
`
`Page 3 of‘)
`
`

`

`Docket No.: CGR500 l USCNTl
`
`47. (Previously presented) The method of claim 46, comprising administering to said
`
`human about 1000 mg/day of abiraterone acetate or a pharmaeeutically acceptable salt
`
`thereof and about 10 mg/day of prednisone.
`
`48. (Previously presented) The method of claim 37, wherein said prostate cancer is
`
`refractory prostate cancer.
`
`49.
`
`(Previously presented) The method of claim 48, wherein the refractory prostate
`
`cancer is not responding to at least one anti—eancer agent.
`
`50. (Previously presented) The method of claim 49, wherein the at least one anti—cancer
`
`agent comprises a hormonal ablation agent, an anti—androgen agent, or an anti—neoplastic
`
`agent.
`
`51. (Previously presented) The method of claim 50, wherein the hormonal ablation agent
`
`comprises deslorelin, leuprolide, goserelin, or triptorelin.
`
`52. (Previously presented) The method of claim 50, wherein the anti—androgen agent
`
`comprises bicalutamide, flutamide, or nilutamide.
`
`53. (Previously presented) The method of claim 50, wherein the anti—neoplastic agent
`
`comprises docetaxel.
`
`Page 4 of 9‘
`
`

`

`Docket No; C(iR500lUSCNTl
`
`54. (Previously presented) The method of claim 48, comprising administering to said
`
`human about 500 mg/day to about
`
`1500 mg/day of abiraterone acetate or
`
`a
`
`pharmaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of
`
`prednisone.
`
`55. (Previously presented) The method of claim 54, comprising administering to said
`
`human about l000 mg/day of abiratcronc acetate or a pharmaccutically acceptable salt
`
`thereof and about 10 mg/day of prcdnisonc.
`
`56. (Previously presented) The method of claim 53, comprising administering to said
`
`human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt
`
`thereof and about 10 mg/day ofprednisone.
`
`Page 5 of 9
`
`

`

`Docket No.: CGR500lUSCNTl
`
`Remarks
`
`Claims 37-56 are pending.
`
`Rejections Under 35 U.S.C. § 103
`
`The rejection of claims 37-56 under 35 USC §l03(a) as allegedly being
`
`unpatcntablc over O’Donell er al.
`
`(B/‘1'Iz's/1 Journal of Cancer 90:23l7—2325 (2004))
`
`(“O’Donell”),
`
`in view of Tannock et al. (Journal 0fClz'm'ca/ Oncology 14:l756—l764
`
`(1996)) (Tannock”) was maintained. Applicant respectfully traverses this rejection.
`
`In Applicant’s previous reply, submitted January ll, 2013 (the “January Reply”),
`
`Applicant submitted the Ryan article,
`
`Ryan showed,
`
`inter alia,
`
`that
`
`the “median
`
`radiographic progression—free survival was 16.5 months with abiraterone~prednisone and
`
`8.3 months with prednisone alone .
`
`.
`
`. Radiographic progression-free survival was
`
`positively correlated with overall survival.” According to the Office,
`
`“the
`
`superior
`
`results of using abiraterone and prednisone together is expected because abiraterone and
`
`prednisone are known to be individually effective in treating prostate cancer. At least
`
`additive effective [sic]
`
`is expected.”
`
`However,
`
`the Office failed to provide any
`
`reasoning to support the expectation of at least an additive effect.
`
`In fact, the Offices‘
`
`own cited an is in opposition to the ()ffice’s statement that at least an additive effect is
`
`expected.
`
`Based on Tannock, the art cited by the Office, one of ordinary skill in the art
`
`would not expect at least an additive effect for overall survival of abiraterone and acetate
`
`and progesterone. Tannock teaches that “[t]herc was no significant difference in overall
`
`survival
`
`[between prednisone
`
`alone
`
`and prednisone plus
`
`the
`
`anticancer
`
`agent
`
`mitoxantrone.]” One of ordinary skill in the art, reading Tannock, would expect there to
`
`be no difference in survival between one cancer agent alone, and that same cancer agent
`
`in combination with prednisone. Thus,
`
`the present
`
`invention possesses unexpected
`
`results and is non—obvious over the cited art.
`
`Further,
`
`the present
`
`invention has displayed commercial success. Applicant
`
`submits herewith the currently United States Food & Drug Administration approved label
`
`Page 6 of 9
`
`

`

`Docket No.: CGR5001USCNTl
`
`for ZYTIGATM (the “ZYTIGA label”). The ZYTIGA label indicates that “[abiraterone
`
`acetate] is a CYPI7 inhibitor indicated in combination with prednisone for the treatment
`
`of patients with metastatic castratiomresistant prostate cancer.” Taking ZYTIGA in
`
`accordance with the approved label represents a commercial embodiment of the presently
`
`claimed invention.
`
`Applicant also submits herewith a news release from the U.S. Food and Drug
`
`Administration dated December 10, 2012 and titled “FDA expands Zytiga’s use for late-
`
`stage prostate cancer.” As can be seen from this 2012 news release, ZYTIGA was
`
`initially approved in April 2011 for use in patients whose prostate cancer progressed after
`
`treatment with doeetaxel. a chemotherapy drug. ZYTIGA was further approved in
`
`December 2012 for use in prostate cancer patients prior to receiving chemotherapy.
`
`Applicant also submits two further news releases from the US. Food and Drug
`
`Administration, one dated June 17, 2010. announcing approval of Jevtana for use in
`
`prostate cancer; and the other dated August 31, 2012, announcing the approval of Xtandi
`
`for use in patients whose prostate cancer progressed after treatment with doeetaxel.
`
`Applicant also submits herewith “Pharmaceuticals Commericial Overview”. a
`
`slideshow presented by Joaquin Duato on May 23, 2013 and currently available at
`
`http://filesshareholder.com/downloads/JNJ/2514173625x0x666408/bb2972ea-2099-
`
`4ab4—b2a3—afc39e710594/Pharmaceutical__Commercial_Overview_JNJ2013.pdf
`
`(the
`
`“20l3 slideshow”). According to the 2013 slideshow, at slide 11, ZYTIGA is the most
`
`successful oral oncology launch in history.
`
`The 2013 slideshow, at slide 12, further shows the July 2012 to April 2013
`
`ZYTIGA market share of chemo refractory prostate cancer patients,
`
`i.c., patients who
`
`have previously received chemotherapy treatment and the December 2012 to April 2013
`
`market share of chemo naive prostate cancer patients,
`
`i.e., patients who have not
`
`previously received chemotherapy treatment. As can be seen from the figure on the left
`
`of slide 12, ZYTIGA had almost 70% market share in July of 2012 for chemo refractory
`
`prostate cancer patients, just slightly over a year after ZYTlGA’s initial approval, and
`
`despite the fact that a JEVTANA had been approved two years earlier. Despite another
`
`product, XTAND1, being introduced in August of 2012, by April of 2013. ZYTIGA was
`
`

`

`Docket No.: CGRSOOIUSCNT1
`
`still the market leader as of April 2013 with 57% market share in chemo refractory
`
`prostate cancer patients.
`
`As can be seen from the figure on the right of slide 12, shortly after its approval
`
`for chemo—nai've patients in December 2012, ZYTIGA had a market share of 15%. As of
`
`April 2013, ZYTlGA’s market share was 20%, higher than two other available therapies,
`
`docetaxel and XTANDL and approaching the market share of biealutamide, a drug first
`
`approved in 2001 for prostate cancer.
`
`Thus, not only is ZYTIGA the most successful oral oncology launch in history,
`
`two years after its initial approval
`
`it
`
`is still the market
`
`leader for chemo refractory
`
`patients despite an earlier—introduced therapy and a later—introduced therapy. ZYTIGA
`
`also holds a strong market share in the chemo naive prostate cancer population, despite
`
`the presence of other marketed products. This commercial success demonstrates the non-
`
`obviousness of the presently claimed invention.
`
`Even assuming, arguendo, the cited art suggests the claimed combination, the
`
`present invention has shown surprising results, and commercial success. Thus, the claims
`
`are non-obvious over the cited art. Accordingly, Applicant requests reconsideration and
`
`withdrawal ofthe rejection under 35 USC §l03(a).
`
`"D S3
`
`OE)(D QC O "G <3
`
`

`

`Docket No.: C(iR500lUSCNTl
`
`III. CONCLUSION
`
`Early consideration and prompt allowance of the claims are respectfully requested.
`
`Should the office require anything further,
`
`it
`
`is
`
`invited to contact Applicants
`
`representative at the telephone number below.
`
`Applicant respectfully requests that a timely Notice of Allowance be issued in the
`
`present application. Should the office require anything further, it is invited to contact
`
`Applicant’s representative at the telephone number below.
`
`JOHNSON & JOHNSON
`One Johnson & Johnson Plaza
`
`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: June 4, 2013
`Customer No.: 27777
`
`Respectfully submitted,
`
`/Andrea Jo Kamage/
`By:
`Andrea Jo Kamagc
`Reg. No. 43,703
`
`Page 9 of 9
`
`

`

`I hereby certify that this correspondence is being transmitted via The Office
`Electronic Filing System (EFS) in accordance with 37 CFR 116(a)(4).
`
`Date offilectronic (EFS) Transmission:
`
`
`June 4 2013
`
`Signature: /Laurie A. Phillips’ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`
`to.KB6.Héafi®.£........ ...tj...X1.é.fi..H...
`§)K§BfiEgfi6HiQ6:?m§i§76§fi;3&6-m-m-m-m-mm-rm-mm.1i£6fi6?gfi?-m-nuTgié-mm-Wm-mmm-wm-wmm-mmw
`§r€Hfigfifié?W"mwwfrébifiéfi/idiéoiimmmm"immmfmfiiahfifiéfimAH'E”séfiidihgiiTnhim””m”“mW”f
`iiiaéiwi“Wm”ii"”iiZ&H66§EndEifififiénnéfiéibiifieanhgtifinci i"W””‘” " ”WTTW”””'m“”””
`
`Mail Stop Amendment
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`NOTICE OF APPEAL
`
`Applicant hereby appeals to the Board of Patent Appeals and interferences from the decision
`
`of the Examiner dated March 4, 2013 Finally rejecting Claims 37-56 of the abovc—idcntificd
`
`application.
`
`The item(s) checked below are appropriate:
`
`EQIZEEEKJElE1
`
`An extension of time to respond to the final rejection was granted on
`rnonth(s).
`A Petition For Extension Of Time under 37 CFR 1.136 is attached hereto in
`
`for
`
`triplicate.
`A timely response to the final rejection has been filed.
`Fee $500.00: for filing ofNotice ofAppea1
`Not required (fee paid in prior appeal)
`Charge to Deposit Account No. 10-0750/AJK/CGR5001.
`The Commissioner is hereby authorized to charge any additional fees which may be
`required, or credit any overpayment in connection herewith to Deposit Account No.
`10-0750/AJK/CGR5001.
`
`Respectfully submitted,
`
`JOHNSON & JOHNSON
`One Johnson & Johnson Plaza
`
`New Brunswick, NJ 08933-7003
`(732) 524-3957
`Dated: June 4, 2013
`Customer No.: 27777
`
`/Andrea J o Kamagc/
`By:
`Andrea Jo Kamage
`Reg. No. 43,703
`
`

`

`£3/4/1.’s’
`
`Press Ai~.nounc:r:ri‘eiiis; > FDA app?-1)\.(‘:Si new ti'eain'ie:ni for 22 type of late ssisagia prostate i2.-sneer
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`FQANEWS RELEASE
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`For Iminediate Reiease: Aug. 31:,
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`The U.S. Fooci and Drug Administration today approved Xtandi ijenzeiutamide} to treat men with iatsrstage
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`therapy‘ to minimize testosterone.
`
`Approved for ;:si“o°>';ete itancer patients §?i’E\a‘iOi,iSi\/ treated with docetmtei, another anti~i:ancer treatment‘,
`Xian-zii was i‘E“v’i€W€d
`under the FiZ3i€x’s
`pri-C.-rity review program. The piogiram provides for an extradited six»
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`in ti’-eatment or that provide a treatment when no
`adequate therapy exists, Xtendi i'e<:eiv=a-d .’~"iZ:-A anorovai ti'ii":.-“:e months ahead of
`g:»i‘ni:iiict’:: pi”esci‘i;?-tion
`di'u-gi user fee goai date of Nov‘ 22, 3012.
`
`-::ontiriu'es to be important for
`“The need for ad-ziitionei treatment. notions for advanced prostate €‘£%.’iC€3i'
`patients,” said Richard Paz-tiur, M.D., direi:toi' -::.-’i’ the iiitfice oi‘ iiernetoiogy and Oncciiogy Pi’-tnucts in FE)A’s
`Carter for Drug Evaiuaticin and Research. “.><t::3ndi is the iatesi; treatment for this disease to dernonstrete its
`ehiiity to <’3?~f1'€:i'iC3 a rsatient’s iiie."
`
`Prcistete -f3E3i‘iCEEi’ fornns in a gian-:1 in the maie rens'oi:iu<:tive system found bei»?«w the biadder and in front of
`the rectum. The mete sex h-3-rmorie testosterone stirnuiates the pnastate tumors to grow. According to the
`Nations! Cancer institute, an estimated Ii-41,7/ivCi men wiii be diagnosed with or-3-state cancer and 28,179 wit
`die from the disease in 2012..
`
`The Safiiiiy and eife<.:i‘iveness oi‘ Xtaridi was eveiiiateti in 533 study of 1,ii99 oat.ieni.s with inc-;ei.esi'ai_ic
`castration» resistant prostate career who had r-r:~i:eivei:i prior treatment with d-metaxei. The study was
`designed to measure overaii suiryiyai (the iength
`time before death) in noen receiving Xtandi compareci
`with men receiving a niacebia (sugar piii). The median -3-yeraii survivai for patients receiving Xtantii was 18.4
`months, cornpared with 13.6 months for the patients who received piacebo.
`
`The most common side ei‘fe_=.<_tts5 observed in study participants ‘taking Xtiandi were we'ai<n-ass or fatigue, haci
`pain, diarrhea, joint pain, hot flush, tissue sweiiing, mus<;iiiosi<eietai pain, headache, zipper re.<.=.pir‘at.<_>ry
`infeizti-3-ns, dizziness, spinai cord -:ornr.ii’essi-on and cauda equine syndrome, i‘i"ii.iSCU§a!’ weaimess, difficulty
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`i-1T-V\'€1i’i‘e&?§3ii’i':3f.Lii"}/
`inie-;tion:~2, biood in urine, tingiing S.-ehseti-:3-n, arixiety, and high bioo-:i pressure.
`
`in apnro><irriai'eiy 1 oerr:.eni: of those receiving ><i‘ani.ii. Patients in the study who had a
`Seizures o<:<;urreci
`seizure :~3to;;ped Xtandi therapy, The tsiinic;-ii study excluded ;:>atients with a his_:.i'ory of srsiziire, an iinderiying
`brain injury with ioss oi‘ c<.>n.<5ciousi‘iess, a i'€'iTip0i‘c'J:")i
`riecrt=_=.asr3 in hiond to tiie hrairi within the r>;=is5i'
`moriths, a .‘5i'F()i'\'E’., brain
`an ahnorrnai ('.’Ofii'!€:‘.'C'£’.iOi"i of
`aria-rie_=.s and 'y'*é3iii.<5.
`in the brain, or
`;:i'etients t.ei<ing r“nedicai'ions that may tower thr-3 s:r3i2ii.ire i‘hi‘eshoid. The c~;aiir_>.ty oi’ Xtandi is iiniinown in
`patients with these conditions.
`
`Xtanszii wiii be co» m;—‘iri<et.e<i by .£\si'eiia.s Pharnia i_i,i3., Inn. of Nortiihrooi<,
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`FDA, an agency within the U8. ijiepertirient of Heaith and iiurren Services, protects the putiiic heaith by
`assuring the safety, eftectiveriess, anti securiizy of human and vetei“inary <:irur;;5:, vaccines and other
`hi-oiogicai pro-citicts for human use, an-ci rredicai devices. The agency aiso is resrtscsnsibie for the safety and
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`\r.~vx~'.f&.go\.i'i\§ ews Eyents/NemroomlPressAnnoumen*ients/ucm3‘i '/'833.htm
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`i/2
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`8/4/'13
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`10. %“:1:tp:;’,’www fda .gov;‘About.FDA/C<>n~t;a(;i;FDA/Fitayinfo rmed/"RSS3Feeds/%3r...ssRefesxses/res.><m§
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`5/4/13
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`Presses; Announczeinents > FDA Aporoxtas New 'i're2aiirieni for Ativanoesi Prosisato C£iii(:£3r
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`Archived Content
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`‘i"iie cxaiitent on this page is iwovicied for reference purposes oniy. it was ittzrrenit wiien
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`FDA NEWS RELEASE
`
`For Emmeriiate Reiease: June 17*, 2i'i:iC
`Media Enqiisiriea: Erica .i<=:i‘t’i=:i:<si'm, 303~79€:-~498i'5,
`Corietsmer Enquiries: 8€i‘z'$--
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`FQA Approves New “treatment for imvaneeei erostate tianezer
`
`i‘~'t;-«:>d aria Cmig Atiministration today approved Jevtana (cabazitaxeiji, a -;:hern:;«ti'ierapy' dru-g used is’
`The U.S.
`ccambiiiaticiii with the stes'oii,i predniaone to treat men with g:ii'ostai:e s:.3nt;er, Jevtana is the first treatment
`for advanced, iioi'imne~i'efras:t<:>ry, prostate cancer that has wc»i'seiie-d during 05' after treatment with
`do-cetaxei, a commonly used cirug for ativanced oiostate cancer;
`
`In prostate cancer, the maie sex hcwmone testositerorze can cause prostate ?,i,35"fiC!i’E‘. to grow, C’i“tif}J, eztsztgery
`or other hormones are used to reduce testosterone piOC'iLiCEiOi’i or to biOCi'\' it,
`?3?f3i’i‘i€ men have i‘:Cii'iTi<Z)i’iE
`refractory’ prostate -cancer, meaning the prostate cancer -rgeiis conitinoe to grow, despite testosflferone
`Si.ip§3i‘<i“.3f3i0i'i. Different treatments are needed for men with this type of <:anc.er_
`
`Jevtana was reviewed uncier the FEWS priority review program, wtiich provides for an expedited si><~mor:th
`review for drugs that may offer major advances in treatnnent, or pr-3-vide a treatment when no adequate
`therapy exists, Jevtana received aporovai ahead of the produ-$i:’s Sept 30, ?:Ci10, goai date,
`
`i‘~i.E3-., director of the
`“Patients have few theragzieiatiz: options in this disease setting," sairri Richard Pazciiir,
`Ciffixze oi" Dricoiogy C’i’Lig Products, part of the FE>A’s Center for Drug Evaiuation and Research. “FDA was
`abie to review and apgar-3-ve the appiication 3“-3-i” Jevtana in 11 weeks, E?)-i§T)€di‘i.'i¥’i~i_.i
`the avaiiabiiiity of this drug
`to men with gm:-state Cancer.”
`
`Jeviianas ssateti; and €3’i:i:£i‘Ci'.iVé‘,‘FiE.%SS was é3S5‘i'5ibiiSi’i£-}C§ in a ssirigie, 755% pai:ient siuriy. Aii study oaniiciparais
`had oreviousiy received ciocemxei. The smtiy was tiiesigneti to measure os/eraii siirvivai {the ieragtri of iirrie
`before deem) in men who receiveti Jevitane in <:onibinaiiir_>ri with pretiriisone compared with Ehosze who
`received tine ciwernoiherapy CiE‘Li{.}, niito.><anti'one,
`in izombinatiori with iaredriiscine. The rneciian -ziveraii emrviva
`for patients receiving the Eevtana regimen was 15.1 months comr>ai‘e~:i with 12.7 months for those wiza-
`received the mitoxantrone regimen.
`
`i're_>.ai‘<-:-.ci with .ic-avtana inctimied decrease in irifers.i'i<;i:i--‘iiginiing \/~Jh5i'€_’. bioori tteiis
`Sicie ei’i‘er_:ta in 'i'.hi.).‘5€
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`biood ithi*ornb<_>cympeoiai, diarrhea, i‘ai'igi..=e, nauszea,
`\/Oi"fli{'ii‘i(_3, ttriristioatiori, weai<nes5 iafineniai, and tens
`Faiiore.
`
`ie the szemttirici moat coirirncm ('.":'mf.‘.i:)i’ among men in the
`Prostate <_:ar'at;er,. wiii<:.i‘i iisiiaiiy occurs in older i’i":E,’.:"E,.
`Liniteiti S$tai'.es, behind skin camter. in 3?,i'_iiJ6, the :“T‘:OSE'.
`i'eC'r':-iii. year for which oumiriers were avaiiabie,
`.T~?.£i3,~"i3iS men deveiopeci orosiiaiie cancer and 28.7372 men died from the rjisea:~3e-, EiC5_‘.iJi’Ciii”ig io
`Cersters
`for Disease Controi and Prexvenimn.
`
`Be-vi;aoa is markeiieti by ikitigewatiezr, i\i.i.--easeti Sanofi--i’-weiitis.
`For more information:
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`iZ3e::is.ion i\ia:<' L '
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`www.fo;a.g oi/iii ews ifvenis/Newsroom/PressAnnouncemenisi’ucm2'i6143.htm
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`814/13
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`Prmss /-\f‘.fE(3£JF3()-B!’Y\(3N‘S > FDA »"«ppru>\e;~s; x*\}e2vv'1'reza1rnenifor A:i\.<an<:e<1 Prcmbate C2if3(3€3€'
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`Links can this page:
`1. http:,’,fwww.fda.gov/AbeutFD:fl/’<Iem;er50fficas/CDER:'u<:mO9I7=<1S.him
`":L:
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`http:/,/wwvv,c«jc.gov,/cemcesy’prostatefénformed ide'3r:§>3ion
`
`§'3“:6§<'.§E’h:;,hi'3T”?
`
`http:,1/www.e:ancerugov,/<:ancarmpic::3/‘types,/gsmstates
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`htt p:_//www fda .gov/AbeL:tF£3A;’Cionta<: ‘CF DA,/Stay§nfcrrmed,"RSSF'
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`is/Ps'ess:'&£:Eeases/s‘5s.>:mé
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`3/2
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`S/4/1.’-I
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`Pi'€'Sé$% Anrzoxirxzeemmis > FDA eaxpsands Z5fi.:ga’sa use for ieazessuaggei ,:;-riasiatee <:2sn(:»:2i'
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`FDANEWS RELEASE
`
`For imivaafiiam Rezziizaasez 139:. 10, $3,012
`Madia Enquiries: Si:epi'iz3nia=: Yaw, 301~79€>~i'3394,
`Consumer Enquiries: 88fs‘~iNFO»Fi'J.£\
`
`::i‘<:,a;:>i"=as'sii:3.yao<T ."x=i
`
`
`Fmx mapamis Zytigws use for Eatewstaga §:)i'(B$§2Ei’iiiE£i cantor
`Drug can now be Lésad before treatment with ci7¢~?mofhe:‘a,{>y
`
`of 7.vi:iga (aiéiraterone acetate)
`The US. Food and Drug Administiaiicsn today e>;r>asm;Eed the api':-raved
`to treat men with iate~stage {metastatic} -:t:a*::tr"z31:iori~resistant
`;'?f'L')53Ydi't§ can-:.,»s~>rs oricnr to z'e~r:e:véa“=g
`szhemotmwapy.
`
`The FDA initiaiiy apprcived Zytiga in Aprii 2011 for use in pafgieiiiss w'h-rm: proéstaiaéé cancer pr-:3.-gressed after
`tnsatment with docetaxiei, a i:hemotE'e-;3ra;>y‘ cirug, Zytiga
`a pm that d<i‘CF€aS0‘,3
`the prodiicti-3-n of rmie 36>:
`hcxrmone: testosteronei
`
`In prostate cancer, testostemne stimuiates pi‘-:3-si:ate tumors to €_tH'DW. Drugs or surgery are used its i'€3{‘3UC€3
`‘testosterone producticin or to i3Eoc.i< tesztostemnes effects. Some men have castratiismresistant prcs="i::~3te
`cancer‘, meaning the prostate cancer’ ceiis c:-?.-Mimie
`grow even with Eow ieveés of testosterone.
`
`“Today's apinrovai demcsnstrates; the bienefii‘. of further evaiuating a mug in an eariier disease setting av-:5
`provides patients and health care proviciers the option of using Zytiga -sariier in the course of treai:meri’t,”
`said R.ichai'-3: P3ZdUi", M‘E:-v)!’ ciirectrgr of the Office of’ Oncciiogy Drug Pi’-.’.?~dUC‘3'.S in me FDA’s Center for Drug
`Evaiuatéon and Research.
`
`:>r'iorii‘y' review prograrn.
`agc~_=.n-::\,,~"‘:~:s
`The FDA reviewrgaaf Zyijigaks appiicaiiion for this new ér:di<,:ai'i:_m under rm-.
`The program provides for an expedited six» rmnth review for drugs thaii may ofiesr rriajor advancies in
`i'r@ai;n“ie=.n£‘ or provide as E‘rea'i_'n'i23n£' when no ade=.q:_aai‘e ’i’h€3rap\_i
`e><isi's.
`
`cEém<_:aE study of 1,€)88 men
`Zyi“:ga’s sé.—ii‘et'.y and e>,f’feci'.ivene2ss for its expanded use were £‘.Si'.éib§§Shé3<.‘£ in
`with Ea£‘e~si’age, cast.ra£'Er_:n«res5is'tan‘t prosiiate cancer who had not prexiiousiy received c:hermiiherapy.
`Participantis reweived eiiiher Zyiiiga or
`piacebra (sugar piii) in c<_:mbinz:iiii<.>n with prednisone.
`
`tie:-"iégried to smasure the t<=:ragti'z of time a §17€.i?Zi£‘.‘l":t Eiveci b<=:for'c=: deatii (moral? survivai) and
`‘The: study
`the iength of tirne a pai'iemi iived wiiihouii f'urther iturnor grovvth as assessed by imaging Si‘.iJC’3i‘E3S (radiczgrapiié
`pro:;;ressicm~‘free survivai, or rPF.‘§).
`
`Eiiatiieritzs who f'€’.CLi‘3i‘./€’Jd Zyiiga had 3 mi=3dian overaii :=,ui\/ivsii of 23S.'.3 rrioi'eths <.iom,:>as'eci with 30.1 months for
`U'i(‘2.‘,'~.£°) reczeivirzg the ;>la<':ebo. Stui:i‘,«‘
`i'e.<_;LiEitr~; aisao sammred Zfytiga impi‘ov'a=:ci
`r‘£33i‘S
`‘Tm: rriedian réfii-'55 was 8.3
`months in the} piacebo _c;r'oi.:p and had not yet E‘;-;-,-5:5: r'ea<';?i-ed for patii,=mt's_:.
`€r'ii2a£-;=2i'i with ;;'ytig53 at the: iTiiT‘iE.‘ of
`“sis.
`
`f=.=i:igaicz, jam: sweiiing or
`ri=:c:eE‘«.'irig Z»,/rigs €m';Euc:i<=:
`The most commore side ef'?e<';ts rr-.>.pori:ed ire €.h0:3<=:
`ciiswmfort, sweiiing caused by fluid ra=.~tenti<.m,
`i':i':=*. ?§U1§i'E, ciiasmiaa, vomitirig, (imfigh, high béood ;>s'es.<.;ure,
`shortness of breatii, urinary‘ tract irifr-action, arid bruiziirig.
`
`The most comrmn Eab<:>ra‘c-5;-ry abmrrriaiities inclueréed tow red i:-iood ceéi count; high Eeveis -3-1‘ the i_=:nzyme
`aikaiine phcssphatasa. which can be a sign of other s-irious rnedicai probiems; high iaveis of fatty acids,
`sugar, and Eiver ~en.zyme:s in the biocwcig and low ie.=.-veis of iymir-hocytes,
`;>h<:»sphorous aim potassium in the
`biooci.
`
`Zytiga is maiketed
`For rmre infc»rmati«3rs:
`
`Horsham, Pa,~based jianss-rim Bi»:-tech Inc.
`
`
`
`‘=~.
`
`.§“§E3i‘:“§3‘?.i1}§Oi'.§‘}f £3 »‘1’}e‘i=\:‘.<:>io\:.;~,.-'
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`Nififit E«‘~msii 6.3? Ca mt fl
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`‘$332554: press rezrisases was updafami‘ on Dec. 3:33, 2522 at 2:36 mm. to mrrecfi‘ the {fate vvhaiz Eyfiga was
`wwvv.fda.g (MN em Events/N ewsmom/F’ressAnnouncements/ucm33 i 4.‘:?2.htm
`1 /2
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