`I hereby certify that this correspondence is being transmitted via The Oft‘im;1
`Electronic Filing System (FIFS) in accordance with 37 CPR l.6(a)(4).
`
`Docket No: ('( iR500 l USCNT l
`
`
`
`
`Date of Electronic (BPS) Transmission:
`
`June 4, 2013
`
`Signature: J'Laurie A. Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`ln re Application of:
`
`Amfiiiéénksjs‘ ‘
`
`"t"Xléii’H‘S‘Aiiéitiééii“W"
`
`Coano
`
`AppllcatlonNOl3/O34340GroupAit
`'
`.
`Februa1y2420ll
`‘
`Ftlngate
`Examiner
`A Title:
`V Methods and Compositions for Treating Cancer
`
`Mail Stop Amendment
`Commissioner for Patents
`PO. 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 |PR2016-01582
`
`JANSSEN EXHIBIT 2167
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`Docket No.: CGR5001 USCNTl
`
`Listing of Claims:
`
`1—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 pharmaceutically 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 pharmaceutically acceptable salt thereof is from
`
`about 50 mg/day to about 2000 mg/day.
`
`39. (Previously presented) The method of claim 38‘ wherein the therapeutically effective
`
`amount of the abiratcrone acetate or pharmaceutically 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 pharmaceutically acceptable salt thereof is about
`
`1000 mg/day.
`
`Page 2 of 9
`
`

`

`Docket No.: C(iRSOOlUSCNTl
`
`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 prednisonc 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 ofthe prednisonc 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 prednisonc is about 10 mg/day.
`
`45. (Previously presented) The method of claim 37, wherein the therapeutically effective
`
`amount of the prednisonc 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 abiraterone acetate or
`
`a
`
`pharmaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of
`
`prednisone.
`
`Page 3 of9
`
`

`

`Docket No.: CGRSOO l USCNTl
`
`47. (Previously presented) The method of claim 46, comprising administering to said
`
`human about 1000 mg/day of abiraterone acetate or a pharmaceutically 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—cancer 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 triptorclin.
`
`52. (Previously presented) The method of claim 50, wherein the anti—androgen agent
`
`comprises biealutamide, 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(iRSOOlUSCNTl
`
`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 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt
`
`thereof and about 10 mg/day of prednisone.
`
`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 N0.: CGRSOOlUSCNTl
`
`Remarks
`
`Claims 37—56 are pending.
`
`Reiections Under 35 U.S.C. § 103
`
`The rejection of claims 37-56 under 35 USC §lO3(a) as allegedly being
`
`unpatcntable over O’Donell et al.
`
`(British Journal of Cancer 90:23l7—2325 (2004))
`
`(“O’Donell”),
`
`in view of Tannock et al. (Journal of Clinical Oncology 14:1756—1764
`
`(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 Office‘s
`
`own cited art is in opposition to the Office’s statement that at least an additive effect is
`
`expected.
`
`Based on Tannoek, 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]here 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 on
`
`

`

`Docket No.: CGRSOOI USCNTl
`
`for ZYTIGATM (the “ZYTIGA label”). The ZYTlGA label indicates that “[abiraterone
`
`acetate] is a CYP17 inhibitor indicated in combination with prednisone for the treatment
`
`of patients with metastatic castration—resistant 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 US. 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 docetaxel, 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://files.shareholder.com/downloads/JNJ/25 14173625x0x666408/bb2972ea-2099-
`
`4ab4-b2a3—afc39e710594/1’harmaceutical__Crommercialeverview_J1\1J2013.deC
`
`(the
`
`“2013 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.e., 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, XTANDJ, being introduced in August of 2012, by April of 2013, ZYTJGA was
`
`

`

`Docket No.: CGRSOOIUSCNTl
`
`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—naive 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 bicalutamide, a drug first
`
`approved in 2001 for prostate cancer.
`
`Thus, not only is ZYTlGA 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 §103(a).
`
`"D S3
`
`0:)(D QC 0 ""i <2
`
`

`

`Docket NO.: C(iRSOOlUSCNTl
`
`III. CONCLUSION
`
`Early consideration and prompt allowance of the claims are respectfully requested.
`
`Should the office require anything further,
`
`it
`
`is
`
`invited to contact Applicant‘s
`
`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 1.6(a)(4).
`
`Date oi‘ElecIronic (EFS) 'l‘ransmission:
`
`June 4 2013
`
`
`
`Signature: /Laurie A, Phillips/ Name: Laurie A. Phillips
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`
`Applicant(s) AlanHAuerbachCoano , 1597
`
`ApplicationNol3/03434OGroupArt
`
`1628
`
`FlllngDateFebruary242011Examiner '
`
`'
`
`' SaanngRHui
`
`i‘iitiéfiw
`
`" ""“"‘finders"at"amassing;rarrmaag“cam; ‘
`
`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 lnterfcrences from the decision
`
`of the Examiner dated March 4, 2013 finally rejecting Claims 37—56 of the above—identified
`
`application.
`
`The item(s) checked below are appropriate:
`
`1.
`
`2.
`
`9’
`
`
`
`[ZIZDXEJ[:1El
`
`An extension of time to respond to the final rejection was granted on
`month(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 oprpeal
`Not required (fee paid in prior appeal)
`Charge to Deposit Account No. 10—0750/AIK/CGR500 l.
`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.2 27777
`
`/Andrca Jo Kamagc/
`By:
`Andrea Jo Kamage
`Reg. No. 43,703
`
`

`

`5/4/13
`
`Press Announcermnis; “2 FDA :apprmesi new treatment for 22 type of lain siege preemies cancer
`
`
`
`i
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`
`FDA NEWS RELEmE
`
`For Immediate Reieaee: Aug. 31, '10:2
`Media inquiring: Erica Jeffereon, 3€)i~~796~4988,
`{Zoneumer Enquiries: 88i’5v-1NFO--FDA
`
`
`{trims}
`
`Fort eopmvee new treatment for ti tyne of into etege proetate cancer
`
`The U8. i‘ooci and Drug Administration today anoreved )(t andi ienzoiutamide) to treat n-3n with iota—stage
`(metastatic) castration~ resistant prostate cancer that has spread or recurred, even with rneciicai or sorgice
`therapy to minimize testosterone.
`
`Approved for prortete cancer patients previonsiv treated with docetoxei, another anti~eancer treatment,
`Xtanoi was reviewed under the Fire’s priority review program. The program provides for an expedited six~
`month review for drugs that may offer major advancee in tree tment or that provided" treatment when no
`adequate therapy exist Xtendi received Fiji/5i an:novait =3 r-i3 months onead of the;3roooct’s precrintion
`dir-ugi useree go‘ai date of Nov 22, 2012
`
`“The need for additia! treatment options tor advanced prostate cancer eontinoes to be important for
`patients,” said Rich 3rd Pazour, MD, director of the Office of Hemetoiogy anri Oncoiogy Products in FDA’S
`Center for Drug Eveioation and Reeeercn. “Xtondi is the ietesi treatment for this disens,e to ciemoia“:trete its
`ehiiity to extend a oatient's iiie.”
`
`Prostate eencer forrre in a giano in the maie reproductive system found beiow the biander anti in front of
`the rectum. The meie sex hormone testosterone stimuiates the prostate tumors to grow. According to the
`Netionai Cancer Institute, an estimated 241,740 rnen wiii be diagnosed with prostate cancer and 28,179 wii
`die from the disease in 2012..
`
`The :aiieiiy and effectiveness of Xtendi was. eveiuated in e etuoy of 1,399 patients with neteetatic
`castratiion resistent prostate cancer who had received prior treatment with deeetaxei. The study was
`designed to measu:e overaii survivai (the iengtn of time before death) in men receiving Xtandi con‘ipareti
`with men receiVing a piacebo (sugar piii). The median overaii survivai for patients receiving Xtanoi was 18.4
`months, compared with 13.6 months; for the patients who received piacebo.
`
`The most common side effects observed in study participants taking Xtendi were weakness or fatigue, haci
`pain, diarrhea, joini pain hot flush, tissue sweiiing, musciiiosireietei pain, headache, upper reepiratory
`infections, dizziness, spinai cordcompression anti cauda equine syndrome, rots-3: cuiar weakness, difficuity
`sieeping, iowerirespiratory infections, biooo in urine, tingiinoemetic-n, anxiety, and high hiooci pressure.
`
`Seizures: 0C:urreci in approxirreteiv i pen; enti thoce receivingYtandi Patiente in the study who hood’
`seizure stopped Xi'andi ther'mipy Tne ciini: oi study exclude-d patenis with a history oi seizure, an underivin:
`brain injury with ios of:macrowiass, a iorrrporey decrease in biooo to the hioin with:in int: priest 12
`months, a stroke, brain netasteses, an ahnormai connection of the arteries and veins.
`in the brain, or
`patients taking medications that may iower the seizure i'iii'eshoid. The safety oi Xi'endi is unknown in
`patients with these conditions.
`
`Xi‘anoi wiii be {30— nerketed by Asi'eiias Pharma i.i.i3., Inc. of {\Jortnorook,
`Francisco, CA.
`For more information:
`
`ii- and iViediVi_ii'sr_in, inc. of {ion
`
`FDA: tittit <2 oi: riei‘xiioxio end Oneoiogy Mineral
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`FDA, an agency within the US, Efepartirient of Heeith and Hurren Services, protects the putriic heaitn by
`assuring the3 safety, effectiveness, anti security of human and veterinary ciruos, vaccines and other
`oi:-iogi~ ai proooucts ror human use, anci neciicai devices. she agency oi so is resnon‘ibie for thesafety and
`security of our nation’s food suppiy, cosmetics, dietary sopoiements, produe ts that give off electronic
`radiation, and for reguieting tobacco products.
`
`#
`
`Mywjo'wgowti ewe Events/Neveroom/PressAnnoumements/ucm'ii 7838htm
`
`1/2
`
`

`

`SW41 3
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`2/2
`
`

`

`5/4/13
`
`Press Announcements > FDA Aporoxes New 'i'reeiiirieni for Advanced Prostate Cancer
`
`
`
`Archived Content
`
`The content on this page is provided for reference purposes oniy. it was current when
`produced, but is no ionger maintained and may be outdated
`
`is};=3
`
`1w‘iimrgi:
`
`
`
`
` 1vg».oo*~3iiimx ‘innoi or
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`FDA NEWS RELEASE
`
`For Emmesiate Reiease: June '7‘2018
`;:-.
`'\
`".
`i i;\'( i Q5“3‘3
`
`Media Enquiries: Erica itttvi‘son, 303 795: 4988 am“ ii-zi.
`Consumer Enquiries: 8823- ii‘ii‘O- iii/i
`
`res. Approves New “treatment far amassed erostate Cancer
`
`The LLS. Food anti"iL rug Aaministration today approved Jevta=13 (cabazitaxei), a chemotherapy drug used ii
`coi11bii1ation with thesteroid precir. isone to tieat men with, upstateC‘aizce r 3eii'tamathe first treatment
`for ativariced, hormone refractory, prostate cancer that has worsened owing or after treatment with
`do:etaxei a commiiiv used cirug foe advanced oi'sotats: cancer.
`
`In prostate cancer, the mafia serif hoririorie testosteronecan cause prostate tumors togrow Diugs, surgery
`or other hormones are us ed to reduce testosterone prodration or to biocix' ii; Some men have iioimorie
`refractory prostate cancer, seaming the prostate cancei :eiis continue to grow, oespite testosterone
`suppression. Different treatments are needed for men with this type of cancer.
`
`Jevtana was reviewed ureter the Films priority review program, which provides for an expedite-ti six~morith
`review for drugs that may offer major advances in treatment, or provide a treatment when no adequate
`therapy exists. Jevtana received approve! ahead of the product’s Sept. 30, 2010, goai date.
`
`“Patients have i‘ewttherapeutic optionSiin this disease setting," saiiri Richard Pazdur ii. [3- director of the
`Citric e of Dru: oiogv Brug Products, part of the FDA’S Center for Drug Evaiuation and Pa search‘‘FDA was
`abie to review and spar-3-ve the ossification to-r Jeiitaria in ii weeks, erpeditir‘iij the avaiiabiiity of this druo
`to men with prostate cancer."
`
`.ieviiaiias sai‘etv and effectiveness was estabiished in a sirigie, 7553* patient study. Aii study participants
`had previousiy receiveri docetaxei. The study was designed to irieas'ure overaii survive! {the ieregtii or time
`before death) in men who received ievtana in ciiiiibination with predoisone compared with the se who
`receivedi.he ciieiriotiiei’apv drug, hiitoxaritrone iii
`i: ombi oatiori with oredrzieone The median overaiisurvive
`for patients receiving the ievtana regimen was 15.1 months compaiesi with 12.7h1or1ihsior those who
`received the iriitoxaritrone regimen.
`
`Side eiitris in those irate;ed with ir-thgiria iriciuried dit reuse in infer. {ion--iiuhiim} whiie biooti :3 oils
`(neutropehio), anemia, decrease ii‘: the number oi white iiiood neii: (ieuiropenioi iow tomi of oiaieiei n ih
`biood (thmmtioi;y’roperiia‘i, diarrhea, fatigue, nausea, vomiting, constipation ’ueokneas (asiheniai, and rem;
`Faiiure.
`
`is the second most common center arming mm in the
`Prostate cancer, whit h usuaiiv occ. urs in aid or men.
`United States, behind skin cancer. in 36306, the :“T‘QSE'. recent year for which members were avaiiabie,
`303,415 men deveioped arostaiie cancer and 28,372. men died from the disease, acrgording to the Centers
`for Disease Controi and Prevention.
`
`.ievtaria is marketed by Bi‘idgewater,
`For more information:
`
`iii.}.--i.iaseri Sarioii--i'-\veiitis.
`
`
`
`VWVW.fd8. g OWN ews Events/N ews roonVPressAnnouncemenis/ucmZ‘i {1‘ 1 43.hti11
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`‘- r13
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`814/1 3
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`Prmss Amouncemnts > FE. Approves; N2w Treat meni for At1wan<1£<1Prc>sba€e Cancer
`
`
`
` Note: If you need hem:
`153A: £118 1:.{\vm
`11111‘? ‘11:. .
`
`
`
`U15. mod am Drug Administration
`10903 New Hampshire Avenue
`Siiver Spring, MD 209393
`P1“; 1 888 ENFC.1—F>EA(1~888 46311332)
`1::“3111 “13A
`
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`Links 01111113» page:
`1.
`http:llwww fda gov/11130111130?/<entersOffices/CDER ucmOgi" ’15 htm
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`1"»)
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`U1«$.5-L»)
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`http:/fvvvwmcdc.gas/{camesy’prostateg’mforrmd ,decisionwnak mg 111:?“
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`http:Alwwxvvnmncerugov;cam:13:10::-iceltypes/§?sfifjfitatifi
`
`
`http:,’/www.fda.gov/AboutFDA/Comet:ti?DA/Stayinfom'zed,/RSSF'
`
`13/Pz'essRafeaw.s/sts. >:me
`
`http: UWWW fda. gov/AboutF LéA/foawctF'DA:gray/InformedMahdi/ucml¢1:1575.1'xtm
`
`vmch'eg (MN ews Events/N ews roomlPressAnmumements/uc m2 1 8143111117
`
`

`

`5/4/13
`
`Press AWFK‘JUFIZQME‘NS > FDA expands nga’s use for iazasiage primate cancer
`
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`FDANEWS RELEASE
`
` .
`
`.
`_.
`‘.
`‘. 0.
`l
`7 J‘iii'omiti‘tr
`
`For immediate Reieasre: Dec. 10, 3012
`Media Enquiries: Stephenie Yao, 301n796~0394, shanghai:iie
`Consumer Enquiries: 888~iNFOvFDA
`
`FEM expands Zytige’s me for iarestage erostate cancer
`Drug can now be used before treatment with 1iiimotive.any
`
`
`
`The us. Food and Drug Administration today emancied the approved use of 7737::icia (aitiraterone acetate)
`to treat men with iate«stage (metastatic) Castrw“on rerirt ht erosion-E can gm?" QiiOi’ to iecewihg
`chemotherapy.
`
`\i
`The FDA initiaiiy approved o1vtiga in Aorii 2011 iCHruse in iai.’ ients who“ {‘mfifd" cancei orrgoress ed after
`treatment with docetaxei, a cheimtiicrem drug, 7ytiga;s a piii that decreases: the orodiictioh of neie sex
`hormone testosterone.
`
`In prostate cancer testosterone stimuiatesoire-state tumors to grow Drugs or surgery are used to reduce
`testosterone production or to biocix‘ttestosteione:: effects. Some men have castration resistant: piO‘"‘l3t8
`cancer meaning the prostate cancer ceiis c-:i’ii‘iniie to.- grow even w:iii“:
`iow ieveis oi testosterone
`
`“Today5 aoprovai demonstrates the benefit. of further evaiuating a drug in an eariier disease setting or.d
`provides patients and Eheaith care providers the option of using Zytiga eariier in the course-of treatmeht,“
`said Richer-a Paxdua; Mi") , director of the Office of" Oncoiogy Drug Products in the FDAS Center for Drug
`Evaiuation and Research.
`
`The, FDA reviewed Zy‘ijiga's aopiicaifiioh for this new indication under i'he agency’s or'iorii‘y review program
`The program provides for an expedited six» rmni'h review for drugsi or. may offer major advances. in
`treatment or provide. a treatment when no adequate therapv e\isrs
`
`Zyrtoo 5 seiety end eiieoiiveness for its expanded use w ere estabiished in a { iigriir ai study of i {in.‘8 men
`with iaCe siage, castraiion resistant prostate. cancer who had not previousiy received Chermiiheraoy.
`Participants received either Zytige or a pieceho (sugar piii) in combination with predoisonei
`
`The. studyw so designed to treasure the iamgti'ito? time a patis ht iived before death (overaii survivai) and
`the iengih of time a paiie hi7 iii/ed wiihoui further tumor growth as assessed by imaging studies (radiogreohi
`progrzssion free eurvivai or CPFF).
`
`Patient: who ieC i"-ived Zy‘i;iga had a media:'i oveeoii sowivoi oil-2L."3 months; (.7 ornoaiC. d with 30 1 months for
`
`those receiving the placebo. Study resuits aim showed nytiga iripiowrd riiif,‘
`rhe- median rid-55 W'as 853
`rrionths in the pieceho group and had not yet been reached for patients Created with Eytige at the More of
`one =‘y’ 5513
`
`The most COi'T‘iiYiOi’i side effects reported in those receiving Zytiga inciode fatigue, joint sweiiihg or
`iiiComfort, sweiiihg caused hv fluid retention hot iiiisri drai'i'i'iea, Vomitirig, cough, high hiood pressure,
`shortness of breath urinary tract infeciion and hruisMing
`
`"i he most common iaboratory abifiormaiities included iow red iziood ceii count; high ieveis-a“ the enzyme
`aikaiine phosphatase. which can be a sign of 0th;:7 serious medicai probiems; high ieveis of fatty acids,
`sugar, and iiver enzymes in the biood; and low ieveis of iymirihocytes; phosphorous and potassium in the
`hiood.
`
`Zytigeis marketed:3v Horsham Pa based iehs. en Biotech inc
`For more inforimtioo:
`
`Fm ogzipiiwes mm id: iati.stage prostate
`
`
`
` ..-'=r Coioiiy {N‘Ci anoioox Moon
`
`Film: hooroved Drugs: Quesi‘iohs:W7lid-wet“
`
`i‘ii’ji: Frost at Ca or; e r‘2
`
`$737353 prees reiease was oedema? on £13ng if} Zfiifi of :2:36:? mm. to Correct tine Crate whey: 25yxige was;
`mvwidag (MN ewe Events/N ewsroonVF’ressAnnouhcementslucmfifj' i AQZhim
`1 i2
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