Abriil 2022: Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) ayaa oggolaaday Opdualag (nivolumab iyo relatlimab-rmbw), Isku darka qiyaasta go'an ee fasalka koowaad ee fasalka koowaad ee nivolumab iyo relatlimab oo lagu maamulo faleebo hal xidid oo xidid ah, oo loogu talagalay daawaynta bukaanka qaangaarka ah iyo carruurta ee da'doodu tahay 12 sano iyo ka weyn oo leh melanoma aan la daboolin ama metastatic. Oggolaanshaha waxay ku salaysan tahay ELATIVITY-047 Wajiga 2/3 daraasadda, taas oo is barbardhigtay Opdualag (n=355) iyo nivolumab kaligiis (n=359) ee dadweynaha bukaanka 355.
Tijaabadu waxay la kulantay barteedii ugu dambaysay, badbaadada-horumar la'aanta (PFS), iyo Opdualag in ka badan laban laabmay dhexdhexaadka PFS marka la barbar dhigo nivolumab monotherapy, bilaha 10.1 (95% Kalsoonida Kalsoonida [CI]: 6.4 ilaa 15.7) oo ka soo horjeeda bilaha 4.6 (95% CI: 3.4 ilaa 5.6); (Hazard Saamiga [HR] 0.75; 95% CI: 0.62 ilaa 0.92, P= 0.0055).1 The Opdualag astaanta badbaadada waxay la mid ahayd tii hore loogu sheegay nivolumab.1,2 Ma jiraan dhacdooyin cusub oo nabdoon oo lagu aqoonsaday isku darka marka la barbar dhigo nivolumab monotherapy.1,2 Fasalka 3/4 dhacdooyinka xun xun ee daroogada la xidhiidha waxay ahaayeen 18.9% gudaha Opdualag cududda marka loo eego 9.7% cududda nivolumab.2 Dhacdooyinka xun xun ee daroogada la xidhiidha ee horseeday joojinta waxay ahaayeen 14.6% gudaha Opdualag cududda marka loo eego 6.7% cududda nivolumab.2
"Tan iyo markii la ansixiyay isbaarada ugu horreysa ee difaaca in ka badan 10 sano ka hor, waxaan aragnay immunotherapy, kaligiis iyo isku darka, isbeddelka daaweynta bukaanada qaba melanoma sare," ayuu yiri F. Stephen Hodi, MD, agaasimaha Xarunta Melanoma iyo Xarunta Immuno-Oncology ee Machadka Kansarka Dana-Farber.3 "Oggolaanshaha maanta ayaa si gaar ah muhiim u ah, sida ay tahay waxay soo bandhigaysaa isku-dar cusub oo cusub oo ah laba daaweyn-immunotherapies kuwaas oo laga yaabo inay wada shaqeeyaan si ay u caawiyaan hagaajinta jawaabta ka hortagga burooyinka iyadoo la beegsanayo laba isbaaro difaac oo kala duwan - LAG-3 iyo PD-1."1,2
Opdualag waxay la xiriirtaa Digniinta iyo Taxadirrada soo socda: falcelin xun oo dhexdhexaad ah oo dhexdhexaad ah oo difaaca jirka ah (IMARs) oo ay ku jiraan pneumonitis, colitis, cagaarshow, endocrinopathy, nephritis oo leh cillad kelyaha, falcelinta maqaarka ee maqaarka, myocarditis iyo falcelinta kale ee dhexdhexaadinta difaaca; falcelinta la xidhiidha faleebo; Dhibaatooyinka ka yimaada tallaalka unugyada unugyada unugyada hematopoietic ee allogeneic (HSCT); iyo sunta uurjiifka.1 Fadlan hoos ka eeg Macluumaadka Badbaadada Muhiimka ah.
"In kasta oo aan horumar weyn ka sameynay daaweynta melanoma horumarsan tobankii sano ee la soo dhaafay, waxaa naga go'an inaan ballaarino fursadaha daaweynta tallaalka tallaalka ee bukaannadan," ayuu yiri Samit Hirawat, madaxa sarkaalka caafimaadka, horumarinta daroogada caalamiga ah, Bristol Myers Squibb.3 "Ka-hortagga LAG-3 ee leh relatlimab, ee isku-darka qiyaasta go'an ee nivolumab, waxay ka dhigan tahay hab daaweyn cusub oo dhisaya dhaxalkayaga inaan u keeno ikhtiyaarro cusub oo tallaalka tallaalka bukaanka. Oggolaanshaha dawo cusub oo ay ku jiraan xannibaadaha saddexaad ee isbaarada ayaa calaamad u ah tallaabo muhiim ah oo hore loo qaaday si loo siiyo bukaannada doorashooyin badan oo ka baxsan daaweynta monotherapy.
Lymphocyte activation gene-3 (LAG-3) iyo barnaamijka dhimashada-1 (PD-1) waa laba isbaaro difaac oo is-hortaag ah oo kala duwan kuwaas oo inta badan lagu muujiyo lymphocytes-ka-faa'iideystayaasha burooyinka, sidaas darteed waxay gacan ka geystaan daalka T-unugga ee buro dhexdhexaad ah.2 Isku darka nivolumab (anti-PD-1) iyo relatlimab (anti-LAG-3) waxay keenaysaa kororka firfircoonida unugyada T-unugga marka la barbar dhigo waxqabadka antibody kaligiis.1 Relatlimab (oo ay weheliso nivolumab) waa unugga-hortagga LAG-3 ee ugu horreeya si loo muujiyo faa'iidada daraasadda Wajiga 3.1 Waa isbaarada saddexaad ee isbaarada (oo ay la socoto anti-PD-1 iyo anti-CTLA-4) ee Bristol Myers Squibb.
"Oggolaanshaha maanta waa war xiiso leh waxayna rajo cusub siinaysaa bulshada melanoma. Helitaanka isku-darka daawaynta waxa laga yaabaa inay u saamaxdo bukaanada inay si macquul ah uga faa'iidaysan karaan laba-immunotherapy-ga cusub, fasalka koowaad, "ayuu yidhi Michael Kaplan, madaxweynaha iyo maamulaha, Melanoma Research Alliance.
Qiyaasta ay FDA oggolaatay ee bukaannada qaangaarka ah iyo bukaannada carruurta ee 12 sano jir ama ka weyn oo miisaankoodu yahay ugu yaraan 40 kg waa 480 mg nivolumab iyo 160 mg relatlimab oo xididka la siiyo afartii toddobaadba mar.1 Qiyaasta lagu taliyey ee loogu talagalay bukaannada carruurta da'doodu tahay 12 sano ama ka weyn oo miisaankoodu ka yar yahay 40 kg, iyo bukaannada carruurta da'doodu ka yar tahay 12 sano, lama dejin.1
Codsigan waxaa lagu ansixiyay barnaamijka tijaabada ah ee FDA ee Real-Time Oncology Review (RTOR), kaas oo ujeedadiisu tahay in la hubiyo in daawaynta badbaadada iyo waxtarka leh ay heli karaan bukaanada sida ugu dhaqsaha badan.4 Dib u eegista ayaa sidoo kale lagu sameeyay hindisaha FDA's Project Orbis, kaas oo awood u siyay dib u eegis isku mid ah oo ay sameeyeen masuuliyiinta caafimaadka ee Australia, Brazil iyo Switzerland, halkaas oo codsiga uu ku jiro dib u eegis.
Ku saabsan Ehelnimada-047
RELATIVITY-047 waa mid caalami ah, randomized, laba-indho la'aan Wajiga 2/3 ee qiimaynaya isku darka qiyaasta go'an ee nivolumab iyo relatlimab ka dhanka ah nivolumab keligiis bukaanada qaba melanoma metastatic ama aan la daweyn karin.1,2 Tijaabadu waxa ay meesha ka saartay bukaanada qaba cudurka difaaca jidhka ee firfircoon, xaaladaha caafimaad ee u baahan daawayn nidaamsan oo leh qiyaas dhexdhexaad ah ama saraysa corticosteroids ama daawooyinka difaaca jirka, uveal melanoma, iyo maskaxda firfircoon ama aan la daawayn ama metastases maskaxda leptomeningeal.1 Meesha ugu dambeysa ee tijaabada waa badbaadada-horumar la'aanta (PFS) ee ay go'aamiso Indho-indhoole Independent Central Review (BICR) iyadoo la adeegsanayo Shuruudaha Qiimaynta Jawaabta ee Burooyinka Adag (RECIST v1.1).1 Dhibcaha ugu dambeeya waa badbaadada guud (OS) iyo heerka jawaabta ujeeddada (ORR).1 Wadarta bukaannada 714 ayaa la kala soocay 1: 1 si ay u helaan isku-darka qiyaasta go'an ee nivolumab (480 mg) iyo relatlimab (160 mg) ama nivolumab (480 mg) faleebo faleebo ah afartii toddobaadba mar ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.1
Ka dooro Xogta Badbaadada QARANKA-047
Dareen-celinta xun ee keenaysa joojinta joogtada ah ee Opdualag ayaa ku dhacay 18% bukaannada.1Opdualag ayaa hakad galay sababtoo ah falcelin xun oo ku dhacday 43% bukaanada.1 Dareen-celin xun ayaa ku dhacay 36% bukaannada lagu daweeyay Opdualag.1 Inta badan (≥1%) dareen-celinta xunxun ee halista ah waxay ahaayeen adrenal-ka oo yaraada (1.4%), dhiig-yaraan (1.4%), colitis (1.4%), oof-wareen (1.4%), wadnaxanuun myocardial oo ba'an (1.1%), dhabar xanuun (1.1% ), shuban (1.1%), myocarditis (1.1%), iyo pneumonitis (1.1%).1 Dareen-celin xun oo dilaa ah ayaa ku dhacay saddex (0.8%) bukaan oo lagu daweeyay Opdualag oo ay ku jiraan hemophagocytic lymphohistiocytosis, barar ba'an ee sambabada, iyo pneumonitis.1 Dareen-celinta xun ee ugu caansan (≥20%) waxay ahaayeen xanuunka muruqyada (45%), daal (39%), finan (28%), cuncun (25%), iyo shuban (24%).1 The Opdualag astaanta badbaadada waxay la mid ahayd tii hore loogu sheegay nivolumab.1,2 Ma jiraan dhacdooyin cusub oo nabdoon oo lagu aqoonsaday isku darka marka la barbar dhigo nivolumab monotherapy.1,2 Fasalka 3/4 dhacdooyinka xun xun ee daroogada la xidhiidha waxay ahaayeen 18.9% gudaha Opdualag cududda marka loo eego 9.7% cududda nivolumab.2 Dhacdooyinka xun xun ee daroogada la xidhiidha ee horseeday joojinta waxay ahaayeen 14.6% gudaha Opdualag cududda marka loo eego 6.7% cududda nivolumab.2
Ku saabsan Melanoma
Melanoma waa nooc ka mid ah kansarka maqaarka oo lagu garto korriinka aan la xakameynin ee unugyada midabka soo saara (melanocytes) ee ku yaal maqaarka.5 Metastatic melanoma waa nooca ugu dhimashada badan ee cudurka waxayna dhacdaa marka kansarku uu ku faafo dusha sare ee maqaarka una gudbo xubnaha kale.5,6 Dhacdooyinka melanoma ayaa si isdaba joog ah u kordhayay 30kii sano ee la soo dhaafay.5,6 Dalka Mareykanka, ku dhawaad 99,780 cudurro cusub oo melanoma ah iyo ilaa 7,650 dhimasho ah ayaa lagu qiyaasay 2022.5 Melanoma inta badan waa la daweyn karaa marka la qabto marxaladaheeda hore; si kastaba ha ahaatee, heerarka badbaadadu way yaraan karaan marka uu cudurku sii socdo.6
Tilmaamaha OPDUALAG
Opdualag TM (nivolumab iyo relatlimab-rmbw) ayaa loo tilmaamay daawaynta dadka waaweyn iyo bukaanka carruurta ee 12 sano jir ama ka weyn oo leh melanoma aan la daboolin ama metastatic.
OPDUALAG MACLUUMAADKA BADBAADADA MUHIIMKA AH
Falcelinno Ad-xun oo Dhimasho-Dhex-dhexaad ah
Dareen-celinta xun ee dhexdhexaadinta difaaca (IMARs) ee halkan ku taxan waxa laga yaabaa inaanay ku jirin dhammaan fal-celinta xun ee dhexdhexaadinta difaaca ee suurtogalka ah.
IMAR-yada laga yaabo inay noqdaan kuwo daran ama dilaa ah, waxay ku dhici karaan hab-dhiska xubnaha ama unug kasta. IMARs waxay dhici karaan wakhti kasta ka dib marka la bilaabo daaweynta LAG-3 iyo PD-1/PD-L1 ee xannibaya unugyada difaaca jirka. Halka IMARs ay badanaa soo muuqdaan inta lagu jiro daawaynta, waxay sidoo kale dhici karaan ka dib joojinta Opdualag. Aqoonsiga hore iyo maamulka IMARs waa lama huraan si loo hubiyo isticmaalka badbaadada leh. Si dhow ula soco bukaanka calaamadaha iyo calamadaha laga yaabo inay yihiin astaamo caafimaad oo IMAR-yada hoose ah. Qiimee kiimikooyinka kiliinikada oo ay ku jiraan enzymes beerka, creatinine, iyo shaqada tayroodh ee gundhigga iyo xilliyada daaweynta. Kiisaska IMAR-yada looga shakisan yahay, billow shaqada ku habboon si looga saaro aadaabta beddelka ah, oo uu ku jiro caabuqa. Machadka maamulka caafimaadka si degdeg ah, oo ay ku jiraan la-tashiga takhasuska sida ku habboon.
Joojinta ama si joogto ah u jooji Opdualag iyadoo ku xidhan darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee macluumaadka Qoritaanka Buuxa ee la socda). Guud ahaan, haddii Opdualag u baahan yahay joojinta ama joojinta, maamul daaweynta corticosteroid systemic (1 ilaa 2 mg/kg/maalintii prednisone ama wax u dhigma) ilaa laga gaadhayo Fasalka 1 ama ka yar. Marka loo horumariyo Fasalka 1 ama ka yar, billow taper corticosteroid oo sii wad inaad duubto ugu yaraan 1 bil. Tixgeli maamulka kale ee difaaca jirka ee bukaannada aan IMARs-kooda lagu xakameyn daawaynta corticosteroid. Tilmaamaha maaraynta sunta ee falcelinta xun ee aan daruuriga ahayn u baahan steroids habaysan (tusaale, endocrinopathy iyo falcelinta maqaarka) ayaa lagaga hadlay hoos.
Oof-wareen-dhexdhexaad ah
Opdualag wuxuu sababi karaa oof-wareenka dhexdhexaadka ah ee difaaca jirka, kaas oo laga yaabo inuu dhinto. Bukaannada lagu daweeyay PD-1/PD-L1 kale ee difaaca unugyada difaaca jirka, dhacdooyinka pneumonitis-ka ayaa ku badan bukaanada helay shucaaca thoracic ka hor. pneumonitis-ku-dhex-dhexaadin ah ayaa ku dhacay 3.7% (13/355) bukaannada qaata Opdualag, oo ay ku jiraan Fasalka 3 (0.6%), iyo Fasalka 2 (2.3%) dareen-celin xun. Pneumonitis-ka ayaa horseeday joojinta joogtada ah ee Opdualag 0.8% iyo joojinta Opdualag 1.4% bukaannada.
Colitis-dhexdhexaad ah
Opdualag wuxuu sababi karaa colitis-ka difaaca jirka, oo lagu qeexay inay u baahan tahay isticmaalka corticosteroids oo aan lahayn etiology kale oo cad. Calaamadaha caadiga ah ee lagu daray qeexida colitis waxay ahayd shuban. Infekshanka cytomegalovirus/dib-u-kicinta ayaa lagu soo warramey bukaanada qaba corticosteroid-ka difaaca difaaca-dhexdhexaadinta colitis. Kiisaska corticosteroid-refractory colitis, ka fiirso ku celcelinta shaqada faafa si aad uga saarto etiologies kale.
Shuban ama colitis-ka difaaca jirka ayaa ku dhacay 7% (24/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 3 (1.1%) iyo Fasalka 2 (4.5%) dareen diidmo. Colitis wuxuu horseeday joojinta joogtada ah ee Opdualag 2% iyo ka joojinta Opdualag 2.8% bukaannada.
Cagaarshowga-dhexdhexaadiyaha ah
Opdualag wuxuu keeni karaa cagaarshow dhexdhexaad ah oo difaaca jirka, oo lagu qeexay inuu u baahan yahay isticmaalka corticosteroids oo aan lahayn etiology kale oo cad.
Cagaarshowga difaaca jirka ayaa ku dhacay 6% (20/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 4 (0.6%), Fasalka 3 (3.4%), iyo Fasalka 2 (1.4%) falcelin xun. Cagaarshowgu wuxuu horseeday joojinta joogtada ah ee Opdualag 1.7% iyo joojinta Opdualag 2.3% bukaannada.
Endocrinopathies-dhexdhexaad ah
Opdualag wuxuu keeni karaa ku filnaan la'aanta adrenal-ka aasaasiga ah ama sare, hypophysitis, cilladaha tayroodhka, iyo nooca 1-aad ee sonkorowga mellitus, kaas oo la joogi kara ketoacidosis sonkorowga. Joojinta ama si joogto ah u jooji Opdualag iyadoo ku xidhan darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee macluumaadka qoritaanka oo buuxa ee la socda).
Fasalka 2 ama ka sarreeya oo ku filnaan la'aanta adrenal, billow daawaynta calaamadaha, oo ay ku jiraan beddelka hormoonnada sida kiliinikada lagu tilmaamay. Bukaannada qaata Opdualag, ku filnaan la'aanta adrenal waxay ku dhacday 4.2% (15/355) bukaannada qaata Opdualag, oo ay ku jiraan Fasalka 3 (1.4%) iyo Fasalka 2 (2.5%) dareen-celin xun. Ku filnaan la'aanta adrenal waxay keentay joojinta joogtada ah ee Opdualag 1.1% iyo ka joojinta Opdualag 0.8% bukaannada.
Hypophysitis waxay soo bandhigi kartaa calaamado ba'an oo la xidhiidha saamaynta ballaaran sida madax-xanuun, sawir-qaadis, ama cillado muuqaal ah. Hypophysitis waxay keeni kartaa hypopituitarism; Bilow beddelka hormoonka sida kiliinikada lagu tilmaamay. Hypophysitis wuxuu ku dhacay 2.5% (9/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 3 (0.3%) iyo Fasalka 2 (1.4%) falcelin xun. Hypophysitis wuxuu horseeday joojinta joogtada ah ee Opdualag 0.3% iyo ka joojinta Opdualag 0.6% bukaannada.
Qanjirka 'thyroiditis' wuxuu la imaan karaa ama la'aanteed endocrinopathy. Hypothyroidism waxay raaci kartaa hyperthyroidism; Bilow beddelka hormoonka ama maamulka caafimaadka sida kiliinikada lagu tilmaamay. Qanjirka 'thyroiditis' wuxuu ku dhacay 2.8% (10/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 2 (1.1%) dareen diidmo. Thyroiditis uma horseedin joojinta joogtada ah ee Opdualag. Qanjirka 'thyroiditis' wuxuu horseeday joojinta Opdualag 0.3% bukaannada. Hyperthyroidism wuxuu ku dhacay 6% (22/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 2 (1.4%) dareen-celinta xun. Hyperthyroidism ma keenin joojinta joogtada ah ee Opdualag. Hyperthyroidism ayaa horseeday joojinta Opdualag 0.3% bukaannada. Hypothyroidism wuxuu ku dhacay 17% (59/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 2 (11%) dareen-celinta xun. Hypothyroidism ayaa horseeday joojinta joogtada ah ee Opdualag 0.3% iyo joojinta Opdualag ee 2.5% bukaannada.
La soco bukaanka hyperglycemia ama calaamadaha kale iyo calaamadaha xanuunka macaanka; ku bilaw daawaynta insulinta sida kiliinikada lagu tilmaamay. Sonkorowga ayaa ku dhacay 0.3% (1/355) bukaanada qaata Opdualag, Fasalka 3 (0.3%) falcelin xun, mana jiraan xaalado ketoacidosis sonkorow. Sonkorowga uma horseedin joojinta joogtada ah ama ka joojinta Opdualag bukaan kasta.
Nephritis-ka difaaca jirka oo leh cillad kelyaha
Opdualag wuxuu sababi karaa nephritis-ka difaaca jirka, kaas oo lagu qeexay inuu u baahan yahay isticmaalka steroids oo aan lahayn etiology cad. Bukaannada qaata Opdualag, nephritis-ka difaaca jirka iyo cilladda kelyaha ayaa ku dhacay 2% (7/355) bukaannada, oo ay ku jiraan Fasalka 3 (1.1%) iyo Fasalka 2 (0.8%) dareen-celin xun. Nephritis-ka difaaca jirka iyo cilladda kelyaha ayaa horseeday joojinta joogtada ah ee Opdualag 0.8% iyo joojinta Opdualag 0.6% bukaannada.
Joojinta ama si joogto ah u jooji Opdualag iyadoo ku xidhan darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee macluumaadka Qoritaanka Buuxa ee la socda).
Dareen-celinta Xun ee Maqaarka-Dhex-dhexaadinta ah
Opdualag waxay sababi kartaa finan difaaca-dhexdhexaad ah ama dermatitis, oo lagu qeexay inay u baahan yihiin isticmaalka steroids oo aan lahayn etiology kale oo cad. dermatitis Exfoliative, oo ay ku jiraan Stevens-Johnson syndrome, necrolysis epidermal sun ah, iyo Finanka Maandooriyaha leh eosinophilia iyo calaamadaha nidaamka ayaa ku dhacay PD-1/L-1 xannibaya unugyada difaaca. Dareen-celinta jirka la mariyo iyo/ama corticosteroids ee jirka la mariyo ayaa laga yaabaa inay ku filnaato in lagu daweeyo finan khafiif ah ama dhexdhexaad ah oo aan exfoliative ahayn.
Joojinta ama si joogto ah u jooji Opdualag iyadoo ku xidhan darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee macluumaadka Qoritaanka Buuxa ee la socda).
Firiiric dhexdhexaad ah oo difaaca jirka ah ayaa ku dhacay 9% (33/355) bukaannada, oo ay ku jiraan Fasalka 3 (0.6%) iyo Fasalka 2 (3.4%) falcelinno aan wanaagsanayn. Finanka difaaca jirka dhexdhexaadka ah uma horseedin joojinta joogtada ah ee Opdualag. Firiiric dhexdhexaad ah oo difaaca jirka ah ayaa horseeday joojinta Opdualag 1.4% bukaannada.
Myocarditis-ka difaaca jirka dhexdhexaadiyay
Opdualag wuxuu sababi karaa myocarditis-ka difaaca jirka, kaas oo lagu qeexay inuu u baahan yahay isticmaalka steroids oo aan lahayn etiology kale oo cad. Ogaanshaha cudurka myocarditis-ka difaaca jirka wuxuu u baahan yahay tuhun sare oo tuhun ah. Bukaanka qaba calaamadaha wadnaha ama wadnaha-sambabada waa in lagu qiimeeyaa myocarditis suurtagal ah. Haddii myocarditis la tuhunsan yahay, xaji qiyaasta, isla markiiba u billow qiyaasta sare ee steroids (prednisone ama methylprednisolone 1 ilaa 2 mg/kg/maalin) oo si degdeg ah u diyaari la-talin wadnaha ah oo leh shaqada ogaanshaha. Haddii bukaan-socodka la xaqiijiyo, si joogto ah u jooji Opdualag ee Fasalka 2-4 ee myocarditis.
Myocarditis wuxuu ku dhacay 1.7% (6/355) bukaanada qaata Opdualag, oo ay ku jiraan Fasalka 3 (0.6%), iyo Fasalka 2 (1.1%) dareen diidmo. Myocarditis wuxuu horseeday joojinta joogtada ah ee Opdualag 1.7% bukaannada.
Falcelisyada Kale ee Diidmada ee Dhexdhexaadka ah
IMAR-yada soo socda ee caafimaad ahaan muhiimka ah waxay ku dhaceen dhacdooyinka <1% (haddii aan si kale loo sheegin) bukaannada la siiyay Opdualag ama lagu soo warramey isticmaalka PD-1/PD-L1 kale ee difaaca jirka. Xaalado daran ama dhimasho ah ayaa laga soo sheegay qaar ka mid ah falcelintan xun: Ccardiac/Vascular: pericarditis, vasculitis; Nidaamka Dareenka: meningitis, encephalitis, myelitis iyo demyelination, myasthenic syndrome/myasthenia gravis (oo ay ku jiraan sii xumeynta), Guillain-Barré syndrome, paresis neerfaha, neuropathy autoimmune; Indhaha: uveitis, iritis, iyo sunta caabuqa kale ee indhaha ayaa dhici karta. Kiisaska qaar ayaa lala xiriirin karaa goynta isha. Heerar kala duwan oo aragga naafada ah, oo ay ku jiraan indho la'aan, ayaa dhici kara. Haddii uveitis uu ku dhaco marka lagu daro IMAR-yada kale, tixgeli Vogt-Koyanagi-Harada-sida syndrome-ka, sababtoo ah tani waxay u baahan kartaa daaweyn leh steroids habaysan si loo yareeyo khatarta aragga ee joogtada ah; Mindhicirka caloosha: pankreatit oo ay ku jiraan korodhka serum amylase iyo heerka lipase, gastritis, duodenitis; Muruqyada iyo Unugyada Isku Xidha: myositis/polymyositis, rhabdomyolysis (iyo kuwa la xiriira oo ay ku jiraan kelyaha oo guul darreystay), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Wax kale (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, habdhiska jawaab-celinta caabuqa, lymphadenitis histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, thrombocytopenic purpura difaaca jirka, diidmada xubin adag xubnaha taranka.
Falcelinnada la Xiriira Faleebada
Opdualag waxay keeni kartaa falcelin daran oo la xidhiidha faleebo. Jooji Opdualag bukaanka leh falcelinno faleebo la xiriira oo daran ama nafta halis gelinaya. Jooji ama gaabis heerka faleebo ee bukaanada leh falcelin la xidhiidha faleebo dhexdhexaad ah ama dhexdhexaad ah. Bukaannada helay Opdualag sida faleebo 60-daqiiqo ah oo faleebo ah, falcelinta faleebada ayaa ku dhacay 7% (23/355) bukaannada.
Dhibaatooyinka Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Dhibaatooyin dilaa ah iyo kuwa kale oo halis ah ayaa ku dhici kara bukaanada hela tallaalka unugyada hematopoietic hematopoietic stem cell (HSCT) ka hor ama ka dib markii lagu daaweeyay PD-1/PD-L1 receptor blocking antibody. Dhibaatooyinka ku-tallaalidda la xiriira waxaa ka mid ah cudurka 'hyperacute graft-versus-host disease' (GVHD), GVHD ba'an, GVHD dabadheeraad ah, cudur veno-occlusive hepatic veno-occlusive ka dib qaboojinta xoogga oo yaraatay, iyo steroid-u baahan qandho-xummad (iyada oo aan la aqoonsan sabab la aqoonsan karo). Dhibaatooyinkan ayaa laga yaabaa inay dhacaan inkastoo daawaynta dhexdhexaadinta u dhaxaysa xannibaadda PD-1/PD-L1 iyo allogeneic HSCT.
Si dhow ula soco bukaanka si aad u hesho caddaynta dhibaatooyinka la xiriira tallaalka oo si degdeg ah u soo farageli. Tixgeli faa'iidada iyo khatarta daawaynta ee PD-1/PD-L1 reseptor xannibaya antibody ka hor ama ka dib HSCT allogeneic.
Sunta Dhibaatada uurjiifka
Iyada oo ku saleysan habkeeda ficilka iyo xogta laga helay daraasadaha xayawaanka, Opdualag waxay sababi kartaa waxyeelo uurjiifka ah marka la siiyo haweeney uur leh. La tali haweenka uurka leh khatarta ka iman karta uurjiifka. La tali dumarka awoodda taranka leh inay isticmaalaan ka-hortag uur wax ku ool ah inta lagu jiro daawaynta Opdualag ugu yaraan 5 bilood ka dib qiyaasta ugu dambeysa ee Opdualag.
Goobaha
Ma jiraan wax xog ah oo ku saabsan joogitaanka Opdualag ee caanaha bini'aadamka, saameynta ilmaha naaska nuujinayo, ama saameynta wax soo saarka caanaha. Sababtoo ah nivolumab iyo relatlimab ayaa laga yaabaa in lagu soo daayo caanaha bini'aadamka iyo sababtoo ah suurtagalnimada falcelinta xun ee ilmaha naaska nuujinayo, kula tali bukaanada inaysan naaska nuujin inta lagu jiro daaweynta Opdualag iyo ugu yaraan 5 bilood ka dib qiyaasta ugu dambeysa.
Falcelinta Xun ee Halis ah
Relativity-047, falcelin xun oo dilaa ah ayaa ku dhacay 3 (0.8%) bukaanada lagu daweeyay Opdualag; Kuwaas waxaa ka mid ah hemophagocytic lymphohistiocytosis, barar ba'an ee sambabada, iyo pneumonitis. Dareen-celin xun ayaa ku dhacay 36% bukaannada lagu daweeyay Opdualag. Dareen-celinta xun ee ugu badan ee lagu soo warramey ≥1% bukaannada lagu daweeyey Opdualag waxay ahaayeen ku filnaansho adrenal (1.4%), dhiig-yaraan (1.4%), colitis (1.4%), oof-wareen (1.4%), Wadnaxanuun myocardial oo daran (1.1%), dhabar xanuunka (1.1%), shuban (1.1%), myocarditis (1.1%), iyo pneumonitis (1.1%).
Dareen-celinta xun ee caadiga ah iyo cilladaha shaybaadhka
Dareen-celinta xun ee ugu badan ee laga soo sheegay ≥20% bukaannada lagu daweeyay Opdualag waxay ahaayeen muruq xanuun (45%), daal (39%), finan (28%), cuncun (25%), iyo shuban (24%).
Dhibaatooyinka shaybaadhka ee ugu caansan ee ka dhacay ≥20% bukaannada lagu daweeyay Opdualag waxay hoos u dhaceen hemoglobin (37%), hoos u dhaca lymphocytes (32%), korodhka AST (30%), korodhka ALT (26%), iyo hoos u dhaca sodium (24). %)
Please see U.S. Full Prescribing Information for Opdualag.
OPDIVO + SHARCIYADA YEERVOY
OPDIVO® (nivolumab), sida hal wakiil, ayaa loo tilmaamay daaweynta bukaanada qaba melanoma aan la soo saari karin ama metastatic.
OPDIVO® (nivolumab), marka lagu daro YERVOY® (ipilimumab), waxaa loogu talagalay daawaynta bukaanada qaba melanoma aan la daboolin ama metastatic.
OPDIVO + MACLUUMAADKA BADBAADADA MUHIIMKA AH EE YERVOY
Falcelinno Ad-xun oo Dhimasho-Dhex-dhexaad ah
Dareen-celinta lidka-difaaca-dhexdhexaadinta ee halkan ku taxan waxa laga yaabaa inaanay ku jirin dhammaan fal-celinta xun ee dhexdhexaadinta difaaca ee suurtogalka ah.
Dareen-celinta xun ee dhexdhexaadinta difaaca jirka, kuwaas oo noqon kara mid daran ama dhimasho, ayaa ku dhici kara nidaamka xubin kasta ama unug kasta. Iyadoo falcelinta xun ee dhexdhexaadinta difaacu ay caadi ahaan soo baxaan inta lagu jiro daawaynta, waxay sidoo kale dhici karaan ka dib joojinta OPDIVO ama YERVOY. Aqoonsiga hore iyo maaraynta waa lama huraan si loo hubiyo isticmaalka badbaadada leh ee OPDIVO iyo YERVOY. La soco calamadaha iyo calaamadaha laga yaabo inay yihiin muuqaalada kiliinikada ee falcelinta xun ee dhexdhexaadinta difaaca jirka. Qiimee kiimikooyinka kiliinikada oo ay ku jiraan enzymes beerka, creatinine, heerka hoormoonka adrenocorticotropic (ACTH), iyo shaqada tayroodh ee gundhigga iyo xilliyada muddada daaweynta OPDIVO iyo ka hor qiyaas kasta oo YERVOY ah. Kiisaska looga shakisan yahay falcelinta xun ee dhexdhexaadinta difaaca, bilow shaqo ku habboon si aad uga saarto aadaabta kale, oo uu ku jiro caabuqa. Machadka maamulka caafimaadka isla markiiba, oo ay ku jiraan la-talinta takhasuska ah sida ku habboon.
Joojinta ama si joogto ah u jooji OPDIVO iyo YERVOY iyadoo ku xiran darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee la socota Xogta Qoritaanka Buuxda). Guud ahaan, haddii OPDIVO ama YERVOY joojinta ama joojinta loo baahdo, maamul daaweynta corticosteroid systemic (1 ilaa 2 mg/kg/maalintii prednisone ama wax u dhigma) ilaa laga gaarayo darajada 1 ama ka yar. Marka loo horumariyo Fasalka 1 ama ka yar, billow taper corticosteroid oo sii wad inaad duubto ugu yaraan 1 bil. Tixgeli maamulka kale ee difaaca jirka ee bukaanka kuwaas oo falcelintooda xun ee dhexdhexaadka ah aan lagu xakameynin daaweynta corticosteroid. Tilmaamaha maaraynta sunta ee falcelinta xun ee aan daruuriga ahayn u baahan steroids habaysan (tusaale, endocrinopathy iyo falcelinta maqaarka) ayaa lagaga hadlay hoos.
Oof-wareen-dhexdhexaad ah
OPDIVO iyo YERVOY waxay sababi karaan oof-wareen dhexdhexaad ah oo difaaca jirka ah. Dhacdooyinka pneumonitis-ka ayaa ku badan bukaanada helay shucaaca xididada hore. Bukaannada qaata OPDIVO monotherapy, pneumonitis-ku-dhexdhexaadiyaha difaaca ayaa ku dhacay 3.1% (61/1994) bukaannada, oo ay ku jiraan Fasalka 4 (<0.1%), Fasalka 3 (0.9%), iyo Fasalka 2 (2.1%).
Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, pneumonitis-ka dhexdhexaadka ah ayaa ku dhacay 7% (31/456) bukaanada, oo ay ku jiraan Fasalka 4 (0.2%), Fasalka 3 (2.0%), iyo Fasalka 2 (4.4%).
Colitis-dhexdhexaad ah
OPDIVO iyo YERVOY waxay sababi karaan colitis-ka difaaca jirka, kaas oo laga yaabo inuu dhinto. Calaamadaha caadiga ah ee lagu daray qeexida colitis waxay ahayd shuban. Cytomegalovirus (CMV) caabuqa/dib-u-kicinta ayaa lagu soo warramey bukaanada qaba corticosteroid-refractory immune-mediated colitis. Kiisaska corticosteroid-refractory colitis, ka fiirso ku celcelinta shaqada faafa si aad uga saarto etiologies kale. Bukaannada qaata OPDIVO monotherapy, colitis-ka difaaca jirka ayaa ku dhacay 2.9% (58/1994) bukaanada, oo ay ku jiraan Fasalka 3 (1.7%) iyo Fasalka 2 (1%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, colitis-ka difaaca jirka ayaa ku dhacay 25% (115/456) bukaanada, oo ay ku jiraan Fasalka 4 (0.4%), Fasalka 3 (14%) iyo Fasalka 2 (8%).
Cagaarshowga-Cagaarshowga- Dhexdhexaadiyaha ah iyo Cagaarshowga
OPDIVO iyo YERVOY waxay keeni karaan cagaarshow-dhexdhexaad ah oo difaaca jirka ah. Bukaannada qaata OPDIVO monotherapy, cagaarshowga dhexdhexaadka ah ee difaaca ayaa ku dhacay 1.8% (35/1994) bukaanada, oo ay ku jiraan Fasalka 4 (0.2%), Fasalka 3 (1.3%), iyo Fasalka 2 (0.4%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, cagaarshowga difaaca jirka ayaa ku dhacay 15% (70/456) bukaanada, oo ay ku jiraan Fasalka 4 (2.4%), Fasalka 3 (11%), iyo Fasalka 2 (1.8%).
Endocrinopathies-dhexdhexaad ah
OPDIVO iyo YERVOY waxay sababi karaan ku filnaansho la'aan adrenal ama sare, hypophysitis difaaca dhexdhexaadinta, cilladaha qanjirka tayroodh ee difaaca jirka, iyo nooca 1 diabetes mellitus, kaas oo keeni kara ketoacidosis sonkorowga. Hayso OPDIVO iyo YERVOY iyadoo ku xidhan darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee macluumaadka la socda ee Buuxa). Fasalka 2 ama ka sarreeya oo ku filnaan la'aanta adrenal, billow daawaynta calaamadaha, oo ay ku jiraan beddelka hormoonnada sida kiliinikada lagu tilmaamay. Hypophysitis waxay soo bandhigi kartaa calaamado ba'an oo la xidhiidha saamaynta ballaaran sida madax-xanuun, sawir-qaadis, ama cillado muuqaal ah. Hypophysitis waxay keeni kartaa hypopituitarism; Bilow beddelka hormoonka sida kiliinikada lagu tilmaamay. Qanjirka 'thyroiditis' wuxuu la imaan karaa ama la'aanteed endocrinopathy. Hypothyroidism waxay raaci kartaa hyperthyroidism; Bilow beddelka hormoonka ama maamulka caafimaadka sida kiliinikada lagu tilmaamay. La soco bukaanka hyperglycemia ama calaamadaha kale iyo calaamadaha xanuunka macaanka; ku bilaw daawaynta insulinta sida kiliinikada lagu tilmaamay.
Bukaannada qaata OPDIVO monotherapy, ku filnaansho la'aanta adrenal ayaa ku dhacday 1% (20/1994), oo ay ku jiraan Fasalka 3 (0.4%) iyo Fasalka 2 (0.6%). Ku filnaansho la'aanta adrenal ayaa dhacday 1% (3/3), oo ay ku jiraan Fasalka 8 (35%), Fasalka 456 (4%), iyo Fasalka 0.2 (3%). Bukaannada qaata OPDIVO 2.4 mg/kg oo leh YERVOY 2 mg/kg 4.2dii asbuuc kasta, ku filnaan la'aanta adrenal ayaa ku dhacday 1% (3/3), oo ay ku jiraan Fasalka 8 (35%), Fasalka 456 (4%), iyo Fasalka 0.2 (3) %)
Bukaannada qaata OPDIVO monotherapy, hypophysitis waxay ku dhacday 0.6% (12/1994) bukaannada, oo ay ku jiraan Fasalka 3 (0.2%) iyo Fasalka 2 (0.3%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii toddobaadba mar, hypophysitis ayaa ku dhacay 9% (42/456), oo ay ku jiraan Fasalka 3 (2.4%) iyo Fasalka 2 (6%).
Bukaannada qaata OPDIVO monotherapy, thyroiditis waxay ku dhacday 0.6% (12/1994) bukaannada, oo ay ku jiraan Fasalka 2 (0.2%).
Bukaannada qaata OPDIVO monotherapy, hyperthyroidism waxay ku dhacday 2.7% (54/1994) bukaanada, oo ay ku jiraan Fasalka 3 (<0.1%) iyo Fasalka 2 (1.2%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, hyperthyroidism ayaa ku dhacay 9% (42/456) bukaanada, oo ay ku jiraan Fasalka 3 (0.9%) iyo Fasalka 2 (4.2%).
Bukaannada qaata OPDIVO monotherapy, hypothyroidism waxay ku dhacday 8% (163/1994) bukaanada, oo ay ku jiraan Fasalka 3 (0.2%) iyo Fasalka 2 (4.8%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, hypothyroidism waxay ku dhacday 20% (91/456) bukaanada, oo ay ku jiraan Fasalka 3 (0.4%) iyo Fasalka 2 (11%).
Bukaannada qaata OPDIVO monotherapy, sonkorowgu wuxuu ku dhacay 0.9% (17/1994) bukaannada, oo ay ku jiraan Fasalka 3 (0.4%) iyo Fasalka 2 (0.3%), iyo 2 xaaladood oo ketoacidosis sonkorowga.
Nephritis-ka difaaca jirka oo leh cillad kelyaha
OPDIVO iyo YERVOY waxay sababi karaan nephritis-ka difaaca jirka. Bukaannada qaata OPDIVO monotherapy, nephritis-ka difaaca jirka iyo cilladda kelyaha ayaa ku dhacay 1.2% (23/1994) bukaannada, oo ay ku jiraan Fasalka 4 (<0.1%), Fasalka 3 (0.5%), iyo Fasalka 2 (0.6%).
Dareen-celinta Xun ee Maqaarka-Dhex-dhexaadinta ah
OPDIVO waxay keeni kartaa finan difaac dhexdhexaad ah ama dermatitis. dermatitis Exfoliative, oo ay ku jiraan Stevens-Johnson syndrome (SJS), epidermal necrolysis sun ah (TEN), iyo finan daroogada leh eosinophilia iyo calaamadaha nidaamka (DRESS) ayaa ku dhacay PD-1/PD-L1 xannibaya unugyada difaaca jirka. Dareen-celinta jirka la mariyo iyo/ama corticosteroids-ka jirka la mariyo ayaa laga yaabaa inay ku filnaato in lagu daweeyo finan khafiif ah ama dhexdhexaad ah.
YERVOY waxay sababi kartaa finan difaaca-dhexdhexaad ah ama dermatitis, oo ay ku jiraan dermatitis bullous iyo exfoliative, SJS, TEN, iyo DRESS. Dareen-celinta jirka la mariyo iyo/ama corticosteroids-ka jirka la mariyo ayaa laga yaabaa inay ku filnaan karaan daawaynta khafiifka ama dhexdhexaadka ah ee aan cagajugleyn/finan-baxa lahayn.
Joojinta ama si joogto ah u jooji OPDIVO iyo YERVOY iyadoo ku xiran darnaanta (fadlan eeg qaybta 2 Qiyaasta iyo Maamulka ee la socota Xogta Qoritaanka Buuxda).
Bukaannada qaata OPDIVO monotherapy, finan difaac dhexdhexaad ah ayaa ku dhacay 9% (171/1994) bukaanada, oo ay ku jiraan Fasalka 3 (1.1%) iyo Fasalka 2 (2.2%). Bukaannada qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, firiiric dhexdhexaad ah ayaa ka dhacay 28% (127/456) bukaanada, oo ay ku jiraan Fasalka 3 (4.8%) iyo Fasalka 2 (10%).
Falcelisyada Kale ee Diidmada ee Dhexdhexaadka ah
Dareen-celinta lidka-difaaca-dhexdhexaadinta ee caafimaad ahaan muhiimka ah ee soo socda ayaa ku dhacay dhacdooyinka <1% (haddii aan si kale loo sheegin) bukaannada helay OPDIVO monotherapy ama OPDIVO oo ay weheliso YERVOY ama lagu soo warramey isticmaalka kale ee PD-1/PD-L1 xannibay. unugyada difaaca jirka. Xaalado daran ama dhimasho ah ayaa lagu soo warramey qaar ka mid ah falcelintan xun: wadnaha/ xididada: myocarditis, pericarditis, vasculitis; habdhiska dareenka: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (oo ay ku jiraan sii xumeynta), Guillain-Barré syndrome, paresis neerfaha, neuropathy autoimmune; indho: uveitis, iritis, iyo sunta caabuqa kale ee indhaha ayaa dhici karta; caloosha iyo mindhicirka: pankreatit si loogu daro korodhka serum amylase iyo heerka lipase, gastritis, duodenitis; murqaha iyo unugyada isku xidha: myositis/polymyositis, rhabdomyolysis, iyo sequelae la xiriira oo ay ku jiraan kelyaha oo fashilma, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; kuwa kale (hematologic/immune): anemia hemolytic, dhiig-yaraan aplastic, hemophagocytic lymphohistiocytosis (HLH), syndrom jawaabta caabuqa habdhiska, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, thrombocytopenic purpura difaaca jirka, diidmada xubin adag xubin.
Marka lagu daro falcelinta xun ee dhexdhexaadinta difaaca jirka ee kor ku taxan, guud ahaan tijaabooyinka kiliinikada ee YERVOY monotherapy ama marka lagu daro OPDIVO, falcelinta difaaca-dhexdhexaadinta kiliinikada ee muhiimka ah ee soo socota, qaar leh natiijo dhimasho ah, ayaa ku dhacday <1% bukaanada haddii aan si kale loo cayimin: habdhiska dareenka: autoimmune neuropathy (2%), myasthenic syndrome / myasthenia gravis, cillad dhaqdhaqaaqa dhaqdhaqaaqa; wadnaha iyo xididada: angiopathy, arteritis ku meel gaar ah; indho: blepharitis, episcleritis, myositis orbital, scleritis; caloosha iyo mindhicirka: pankreatit (1.3%); kuwa kale (hematologic/immune): conjunctivitis, cytopenia (2.5%), eosinophilia (2.1%), erythema multiforme, vasculitis hypersensitivity, hypoacusis neurosensory, psoriasis.
Qaar ka mid ah xaaladaha IMAR ee indhaha ayaa lala xiriirin karaa goynta isha. Heerar kala duwan oo aragga naafada ah, oo ay ku jiraan indho la'aan, ayaa dhici kara. Haddii uveitis ay ku dhacdo iyada oo ay weheliso falcelin-xumo kale oo dhexdhexaadin ah, tixgeli Vogt-Koyanagi-Hrada-sida syndrome-ka, kaas oo lagu arkay bukaannada qaata OPDIVO iyo YERVOY, sababtoo ah tani waxay u baahan kartaa daaweynta corticosteroids habaysan si loo yareeyo khatarta aragga joogtada ah. khasaaro.
Falcelinnada la Xiriira Faleebada
OPDIVO iyo YERVOY waxay keeni karaan falcelin daran oo la xidhiidha faleebo. Jooji OPDIVO iyo YERVOY bukaanada qaba dareen-celin la xiriirta faleebo (Fasalka 3) ama nafta halis gelinaya. Jooji ama gaabis heerka faleebo ee bukaanada qaba falcelinta la xidhiidha faleebo khafiif ah (Fasalka 4) ama dhexdhexaad (Darajada 1).
Bukaannada qaata OPDIVO monotherapy sida faleebo 60-daqiiqo ah, falcelinta faleebo ayaa ku dhacay 6.4% (127/1994) bukaannada. Tijaabo gaar ah oo bukaannada ay heleen OPDIVO monotherapy sida faleebo 60-daqiiqo ah ama faleebo 30-daqiiqo ah, fal-celinta faleebada ayaa ka dhacay 2.2% (8/368) iyo 2.7% (10/369) bukaannada, siday u kala horreeyaan. Intaa waxaa dheer, 0.5% (2/368) iyo 1.4% (5/369) ee bukaanada, siday u kala horreeyaan, waxay la kulmeen falcelin xun gudahood 48 saacadood faleebo taasoo keentay dib u dhigista qiyaasta, joojinta joogtada ah ama joojinta OPDIVO.
Bukaannada melanoma ee qaata OPDIVO 1 mg/kg oo leh YERVOY 3 mg/kg 3dii asbuuc kasta, falcelinta faleebo ayaa ku dhacay 2.5% (10/407) bukaanada.
Dhibatooyinka Allogeneic Hematopoietic Stem Cell Transplantation
Dhibaatooyin dilaa ah iyo kuwo kale oo halis ah ayaa ku dhici kara bukaanada hela tallaalka unugyada hematopoietic stem cell (HSCT) ka hor ama ka dib daawaynta OPDIVO ama YERVOY. Dhibaatooyinka ku-tallaalidda la xiriira waxaa ka mid ah graft-acute hyperacute-versus-host-cudurka (GVHD), GVHD ba'an, GVHD daba-dheer, cudur-sidaha veno-occlusive-ka (VOD) ka dib marka la yareeyo qaboojinta xoojinta, iyo steroid-u baahan qandho-xummad (iyada oo aan la aqoonsan sabab la is qaadsiiyo). Dhibaatooyinkan ayaa laga yaabaa inay dhacaan inkastoo daawaynta dhex galka ah ee u dhaxaysa OPDIVO ama YERVOY iyo allogeneic HSCT.
Si dhow ula soco bukaanka si aad u hesho caddaynta dhibaatooyinka la xiriira tallaalka oo si degdeg ah u soo farageli. Tixgeli faa'iidada iyo khatarta daawaynta OPDIVO iyo YERVOY ka hor ama ka dib HSCT allogeneic.
Sunta Dhibaatada uurjiifka
Iyada oo ku saleysan habkeeda ficilka iyo natiijooyinka daraasadaha xayawaanka, OPDIVO iyo YERVOY waxay sababi karaan waxyeelo uurjiifka ah marka la siiyo haweeney uur leh. Saamaynta YERVOY waxay u badan tahay inay sii weynaato inta lagu jiro saddexda bilood ee labaad iyo saddexaad ee uurka. La tali haweenka uurka leh khatarta ka iman karta uurjiifka. La tali dumarka awoodda taranka leh inay isticmaalaan ka-hortag uur waxtar leh inta lagu jiro daawaynta OPDIVO iyo YERVOY iyo ugu yaraan 5 bilood ka dib qiyaasta ugu dambeysa.
Dhimashada kordhaysa ee Bukaannada qaba Myeloma-da badan marka OPDIVO lagu daro Thalidomide Analogue iyo Dexamethasone
Tijaabooyin caafimaad oo aan kala sooc lahayn oo lagu sameeyay bukaanada qaba myeloma badan, ku darida OPDIVO ee analooga thalidomide iyo dexamethasone waxay keentay dhimashada korodhka. Daawaynta bukaanada qaba myeloma badan oo leh PD-1 ama PD-L1 oo xannibaya antibody oo ay weheliso analoogga thalidomide iyo dexamethasone laguma talinayo ka baxsan tijaabooyinka caafimaad ee la kantaroolay.
Goobaha
Ma jiraan xog ku saabsan joogitaanka OPDIVO ama YERVOY ee caanaha bini'aadamka, saameynta ilmaha naaska nuujinayo, ama saameynta wax soo saarka caanaha. Sababtoo ah suurtagalnimada falcelinta xun xun ee carruurta naaska nuujinaysa, kula tali haweenka inaysan naaska nuujin inta lagu jiro daaweynta iyo 5 bilood ka dib qiyaasta ugu dambeysa.
Falcelinta Xun ee Halis ah
Checkmate 037, falcelin xun xun ayaa ku dhacay 41% bukaanada qaata OPDIVO (n=268). Fasalka 3 iyo 4 falcelin xun ayaa ku dhacay 42% bukaanada qaata OPDIVO. Fasalka 3 iyo 4 falcelinta daroogada xun ee soo noqnoqda ee laga soo sheegay 2% ilaa <5% bukaanada qaata OPDIVO waxay ahaayeen calool xanuun, hyponatremia, kororka aminotransferase aspartate, iyo lipase kordhay. Checkmate 066, falcelin xun xun ayaa ku dhacay 36% bukaanada qaata OPDIVO (n=206). Fasalka 3 iyo 4 falcelin xun ayaa ku dhacay 41% bukaanada qaata OPDIVO. Dareen-celinta ugu badan ee Fasalka 3 iyo 4 ee laga soo sheegay ≥2% bukaannada qaata OPDIVO waxay ahaayeen korodhka gamma-glutamyltransferase (3.9%) iyo shuban (3.4%). In Checkmate 067, falcelin xun oo halis ah (74% iyo 44%), falcelin xun oo horseedaya joojinta joogtada ah (47% iyo 18%) ama daahitaanka qiyaasta (58% iyo 36%), iyo Fasalka 3 ama 4 falcelin xun (72% iyo 51%) dhamaantood waxay si isdaba joog ah uga dhaceen OPDIVO iyo cudud YERVOY (n=313) marka loo eego cududa OPDIVO (n=313). Dareen-celinta xunxun ee ugu badan (≥10%) ee OPDIVO iyo cududda YERVOY iyo cududda OPDIVO, siday u kala horreeyaan, waxay ahaayeen shuban (13% iyo 2.2%), colitis (10% iyo 1.9%), iyo pyrexia (10% iyo 1.0). %)
Dareennada Xun ee Caadiga ah
Checkmate 037, falcelinta xun ee ugu caansan (≥20%) ayaa laga soo sheegay OPDIVO (n=268) waxay ahayd finan (21%). In Checkmate 066, falcelinta xun ee ugu caansan (≥20%) ayaa lagu soo warramey OPDIVO (n=206) vs dacarbazine (n=205) waxay ahaayeen daal (49% vs 39%), xanuunka murqaha (32% vs 25%), finan (28% vs 12%), iyo cuncun (23% vs 12%). Checkmate 067, falcelinta xun ee ugu badan (≥20%) ee OPDIVO iyo cudud YERVOY (n=313) waxay ahaayeen daal (62%), shuban (54%), finan (53%), lallabbo (44%), pyrexia (40%), cuncun (39%), xanuunka muruqyada (32%), matag (31%), cunto xumo (29%), qufac (27%), madax xanuun (26%), dyspnea (24%), Infekshanka habka neef-mareenka sare (23%), arthralgia (21%), iyo kororka transaminases (25%). In Checkmate 067, falcelinta xun ee ugu caansan (≥20%) ee cududda OPDIVO (n=313) waxay ahaayeen daal (59%), finan (40%), xanuunka muruqyada (42%), shuban (36%), lallabbo (30%), qufac (28%), cuncun (27%), caabuqa habka neef-mareenka sare (22%), rabitaanka cuntada oo yaraada (22%), madax xanuun (22%), calool istaag (21%), arthralgia (21%) iyo matag (20%).
Please see US Full Prescribing Information for OPDIVO and YERVOY.
Bristol Myers Squibb: Abuuritaanka mustaqbal wanaagsan oo loogu talagalay dadka qaba kansarka
Bristol Myers Squibb waxa dhiirigeliyay hal aragti - oo nolosha bukaanka u beddelaysa saynis. Hadafka cilmi-baarista kansarka ee shirkadu waa in la keeno dawooyinka siinaya bukaan kasta nolol ka wanaagsan, nolol caafimaad leh iyo in laga dhigo daweyn suurtagal ah. Dhisidda dhaxal ka dhan ah noocyo badan oo kansar ah kuwaas oo beddelay rajada badbaadada ee dad badan, cilmi-baarayaasha Bristol Myers Squibb waxay sahamiyaan xuduudo cusub oo daawo shakhsi ah, iyo iyada oo loo marayo aalado dhijitaal ah oo cusub, ayaa xogta u rogaya aragtiyo xoojinaya diiradda. Khibrad cilmiyeed oo qoto dheer, awoodaha goynta iyo aaladaha daahfurka ayaa u sahlaya shirkadu in ay xagal kasta ka eegto kansarka. Kansarku waxa uu si aan kala joogsi lahayn u qabsan karaa qaybo badan oo ka mid ah nolosha bukaanka, Bristol Myers Squibb waxa ka go'an in ay qaado tillaabooyin wax looga qabanayo dhammaan dhinacyada daryeelka, laga bilaabo ogaanshaha ilaa badbaadada. Sababtoo ah hogaamiye ka ah daryeelka kansarka, Bristol Myers Squibb waxay ka shaqaynaysaa inay awood u yeelato dhammaan dadka qaba kansarka si ay u yeeshaan mustaqbal wanaagsan.
Ku saabsan Taageerada Helitaanka Bukaanka ee Bristol Myers Squibb
Bristol Myers Squibb waxa ay wali ka go'an tahay bixinta caawimada si bukaanada kansarka ee u baahan dawooyinkeena ay u helaan oo ay u dedejiyaan wakhtiga daawaynta.
Taageerada Helitaanka BMS®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
Ku saabsan Bristol Myers Squibb iyo Iskaashatada Daawooyinka ee Ono
Sannadkii 2011, iyada oo loo marayo heshiis iskaashi oo lala galay shirkadda Ono Pharmaceutical Co., Bristol Myers Squibb waxay ballaarisay xuquuqdeeda dhuleed si ay u horumariso oo ay uga ganacsato Cajiib caalamka, marka laga reebo Japan, South Korea iyo Taiwan, halkaas oo Ono ay haysay dhammaan xuquuqaha xarunta wakhtigaas. Bishii Luulyo 23, 2014, Ono iyo Bristol Myers Squibb waxay sii balaadhiyeen heshiiska istaraatiijiyadeed ee shirkadaha si ay si wadajir ah u horumariyaan oo ay ganacsi uga dhigaan noocyo badan oo tallaalka difaaca ah - oo ah wakiillo keliya iyo hababka isku dhafan - ee bukaannada qaba kansarka ee Japan, South Korea iyo Taiwan.
Ku saabsan Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Celgene iyo Juno Therapeutics waa shirkado la wada leeyahay Bristol-Myers Squibb Shirkadda. Waddamo gaar ah oo ka baxsan Maraykanka, sharciyada maxalliga ah awgeed, Celgene iyo Juno Therapeutics waxaa loo tixraacaa sida, Celgene, a Bristol Myers Squibb company iyo Juno Therapeutics, a Bristol Myers Squibb company.
Bayaanka Digniinta ah ee Ku Saabsan Bayaanka Hordhaca ah
War-saxaafadeedkan waxa uu ka kooban yahay "odhaahyo hore u socda" oo ku dhex jira macnaha Xeerka Dib-u-habaynta Dammaanad-qaadka Dammaanadda Gaarka ah ee 1995 ee ku saabsan, iyo waxyaabo kale, cilmi-baarista, horumarinta iyo ganacsi-ganacsiga alaabta dawooyinka. Dhammaan odhaahyada aan ahayn bayaannada xaqiiqooyinka taariikhiga ah waa, ama laga yaabaa in loo arko inay yihiin hadallo mustaqbalka fog leh. Odhaahyada mustaqbalka ee noocan oo kale ah waxay ku salaysan yihiin rajooyinka hadda jira iyo saadaalinta ku saabsan natiijooyinka maaliyadeed ee mustaqbalka, yoolalka, qorshayaasha iyo ujeedooyinka waxayna ku lug leeyihiin khataro, malo iyo hubanti la'aan, oo ay ku jiraan arrimo gudaha ama dibadda ah oo dib u dhigi kara, leexin kara ama bedeli kara mid ka mid ah soo socda dhawr sano, oo ay adag tahay in la saadaaliyo, waxa laga yaabaa inay ka baxsan yihiin xakamayntayada waxayna sababi karaan natiijooyinkeena maaliyadeed mustaqbalka, yoolalka, qorshayaasha iyo ujeedooyinka inay ka duwanaadaan kuwa lagu sheegay, ama lagu tilmaamay, bayaanada. Khatarahan, malo-awaalka, hubanti-la'aanta iyo arrimo kale waxaa ka mid ah, iyo kuwo kale, haddii OpdualagTM (nivolumab iyo relatlimab-rmbw) ganacsi ahaan waxay ku guulaysan doonaan tilmaanta lagu sifeeyay war-saxaafadeedkan, oggolaansho kasta oo suuqgeyneed, haddii la bixiyo, waxay yeelan kartaa xaddidaadyo la taaban karo oo ku saabsan isticmaalkooda, iyo in la sii wado oggolaanshaha musharraxa badeecada ee tilmaantan lagu sharraxay saxaafaddan. sii dayntu waxay ku xidhan tahay xaqiijinta iyo sharaxaada faa'iidooyinka caafimaad ee tijaabooyinka xaqiijinta. Ma jiro hadal mustaqbalka fog leh oo la dammaanad qaadi karo. Odhaahyada mustaqbalka ee war-saxaafadeedkan waa in lagu qiimeeyaa iyada oo ay weheliso khataro badan iyo hubanti la'aan saamaynaysa ganacsiga iyo suuqa Bristol Myers Squibb, gaar ahaan kuwa lagu aqoonsaday bayaanka digniinta iyo arrimaha khatarta ah ee ku jira Warbixinta Sannadlaha ah ee Bristol Myers Squibb ee Foomka 10-K sanadka dhamaaday Diisambar 31, 2021, sida lagu cusboonaysiiyay Warbixinadayada rubuc-billaha ah ee soo socda ee Foomka 10-Q, Warbixinada Hadda ee Foomka 8-K iyo faylgaraynta kale ee Guddida Ilaalinta iyo Sarrifka. Odhaahyada mustaqbalka-muuqaalka ah ee ku jira dukumeentigan waxa la sameeyey oo keliya laga bilaabo taariikhda dukumeentigan iyo marka laga reebo sida kale ee uu u baahan yahay sharciga khuseeya, Bristol Myers Squibb wax waajib ah kama saarna inay si guud u cusboonaysiiso ama dib-u-eegis ku samayso qoraal kasta oo mustaqbalka ah, haddii ay tahay natiijada macluumaad cusub, dhacdooyinka mustaqbalka, duruufaha bedelay ama si kale.
tixraacyada
- Opdualag Macluumaadka qorista. Opdualag Macluumaadka Alaabta Mareykanka. Markii ugu dambeysay ee la cusbooneysiiyay: Maarso 2022. Princeton, NJ: Shirkadda Bristol-Myers Squibb.
- Tawbi HA, Schadendorf D, Lipson EJ, iyo al. Relatlimab iyo nivolumab iyo nivolumab oo ku jira melanoma horumarsan ee aan la daweyn. N Engl J Med. 2022; 386: 24-34.
- Hodi FS, Chiarion-Sileni V, Gonzalez R, iyo al. Nivolumab oo lagu daray ipilimumab ama nivolumab kaligiis iyo ipilimumab oo kali ah melanoma horumarsan (CheckMate 067): Natiijooyinka 4-sano ee xarun badan, randomized, tijaabada wajiga 3. Lancet Oncol. 2018;19(11): 1480-1492.
- Maamulka Cuntada iyo Dawooyinka ee Maraykanka. Barnaamijka Tijaabada Dib-u-Eegista Oncology-Waqtiga Dhabta ah.
