JANUARY 27, 2023-Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), oo ah shirkad caalami ah oo bayotechnoolajiyadda horumarisa, soo saarista iyo ka-ganacsiyeedka daaweynta cusub ee lagu daweynayo cudurrada nolosha-khatarta ah, ayaa maanta lagu dhawaaqay in CARTITUDE-4, daraasadda Wajiga 3 ee lagu qiimeeyo CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) ee loogu talagalay daawaynta bukaanada qaangaarka ah ee leh dib-u-soo-kabashada iyo lenalidomide-refractory multiple myeloma, waxay la kulantay barta ugu dambeysa ee muujinta horumar la taaban karo oo ku saabsan badbaadada horumarka-la'aanta ah (PFS) marka la barbar dhigo daaweynta caadiga ah ee daraasadda ugu horreysa ee falanqaynta ku meel gaarka ah ee hore loo cayimay. . Daraasaddu waa indho la'aan iyadoo la raacayo soo jeedinta guddiga kormeerka xogta ee madaxbannaan.
Daraasadda CARTITUDE-4 (NCT04181827) waa daraasaddii ugu horreysay ee caalami ah, la kala soocay, calaamad furan oo Wajiga 3 ah oo qiimeynaysa waxtarka iyo badbaadada daaweynta CAR-T oo ka soo horjeeda pomalidomide, bortezomib iyo dexamethasone (PVd) ama daratumumab, pomalidomide iyo dexamethasone (DP) Bukaannada qaangaarka ah ee leh dib-u-soo-kabashada iyo lenalidomide-refractory multiple myeloma kuwaas oo helay hal ilaa saddex xariiq oo hore oo daaweyn ah.
Meesha ugu dambeysa ee daraasadda waa PFS. Dhibcaha labaad ee ugu dambeeya waxaa ka mid ah badbaadada, badbaadada guud (OS), cudurka ugu yar ee haraaga ah (MRD) heerka taban iyo heerka jawaabta guud (ORR). Bukaan-socodka ayaa sii wadi doona in loo raaco dhibcaha ugu dambeeya ee aasaasiga ah iyo kuwa sare iyada oo qayb ka ah daraasadda CARTITUDE-4.
“Autologous CAR-T cell therapy represents a major breakthrough in cancer treatment, and topline results from CARTITUDE-4 support our continuous efforts to bring this treatment option to patients with Meelo badan in various stages of disease progression,” Lida Pacaud, M.D., Vice President of Clinical Development and Medical Affairs at Legend Biotech, said.
Natiijooyinka ka soo baxay daraasadda CARTITUDE-4 waxaa loo gudbin doonaa kulan caafimaad oo soo socda waxayna taageeri doontaa wadahadalada lala yeesho maamulka caafimaadka ee ku saabsan soo gudbinta sharciyeed ee suurtagalka ah.
CARVYKTI® Tilmaamaha iyo Isticmaalka
CARVYKTI® (ciltacabtagene autoleucel) waa antigen-ka korriinka B-cell (BCMA) –ku- haga hidde ahaan wax laga beddelay T unugga immunotherapy loogu talagalay daawaynta bukaanada qaangaarka ah ee leh dib-u-soo-kabashada ama dib-u-celinta multiple myeloma, ka dib afar ama in ka badan oo hore oo daaweyn ah, oo ay ku jiraan proteasome inhibitor, wakiilka immunomodulatory, iyo anti-CD38 monoclonal antibody.
DIGNIINTA IYO KA HORTAGA
CYTOKINE RELEASE SYNDROME (CRS) oo ay ku jiraan falcelinno dilaa ah ama nafta halis gelinaya, ayaa dhacay ka dib daawaynta CARVYKTI® 95% (92/97) bukaanada qaata ciltacabtagene autoleucel. Fasalka 3 ama ka sareeya CRS (2019 ASTCT) ayaa ku dhacay 5% (5/97) bukaanada, iyadoo darajada 5 CRS laga soo sheegay 1 bukaan. Waqtiga dhexe ee bilawga CRS wuxuu ahaa 7 maalmood (kala duwan: 1-12 maalmood). Calaamadaha ugu caansan ee CRS waxaa ka mid ah pyrexia (100%), hypotension (43%), kororka aminotransferase aspartate (AST) (22%), qarqaryo (15%), alanine aminotransferase (ALT) oo kordhay (14%) iyo tachycardia sinus 11%) Fasalka 3 ama dhacdooyinka ka sarreeya ee la xidhiidha CRS waxaa ka mid ah AST iyo ALT oo kordhay, hyperbilirubinemia, hypotension, pyrexia, hypoxia, neefsashada oo xumaada, dhaawac kelyo ah oo ba'an, xinjirowga xididdada dhiigga ee la faafiyey, HLH/MAS, angina pectoris, tachycardia supraventricular iyo ventricular tachycardia, xanuunka, myalgias, kordhay borotiinka C-reactive, ferritin, fosfatase alkaline dhiiga iyo gamma-glutamyl transferase.
Aqoonso CRS iyada oo ku saleysan bandhigga bukaan-socodka. Qiimee oo daaweeya sababaha kale ee qandho, hypoxia, iyo hypotension. CRS ayaa lagu soo warramey in ay la xiriirto natiijooyinka HLH/MAS, iyo physiology of syndromes-ka ayaa laga yaabaa in ay isdhaafsadaan. HLH/MAS waa xaalad nafta halis gelin karta. Bukaannada leh calaamadaha horumarka ee CRS ama CRS-da refractory inkastoo daawaynta, qiimee caddaynta HLH/MAS.
Lixdan iyo sagaal ka mid ah 97 (71%) bukaanada ayaa helay tocilizumab iyo/ama corticosteroid ee CRS ka dib faleebo ciltacabtagene autoleucel. Afartan iyo afar (45%) bukaanada ayaa helay tocilizumab kaliya, kuwaas oo 33 (34%) ay heleen hal qiyaas iyo 11 (11%) waxay heleen in ka badan hal qiyaas; 24 bukaan (25%) ayaa helay tocilizumab iyo corticosteroid, iyo hal bukaan (1%) ayaa helay kaliya corticosteroids. Hubi in ugu yaraan laba qiyaasood oo tocilizumab ah la heli karo ka hor faleebada CARVYKTI®.
La soco bukaanka ugu yaraan maalin kasta 10 maalmood ka dib CARVYKTI® faleebo laga helo xarunta daryeelka caafimaadka ee REMS-shahay ee calaamadaha iyo calaamadaha CRS. La soco bukaanka calaamadaha ama calaamadaha CRS ugu yaraan 4 toddobaad ka dib faleebo. Calaamadda ugu horreysa ee CRS, isla markiiba u bixi daawaynta daryeelka taageerada, tocilizumab, ama tocilizumab iyo corticosteroids.
La tali bukaanka inay raadsadaan daryeel caafimaad degdeg ah haddii calaamadaha ama calaamadaha CRS ay dhacaan wakhti kasta.
SUNOOYINKA NUUROLOGIGA, Kaas oo noqon kara mid daran, nafta halis gelin kara ama dhimasho, dhacay ka dib daawaynta CARVYKTI®. Sunta neerfaha waxaa ka mid ah ICANS, sunta neerfaha oo leh calamadaha iyo calaamadaha Parkinsonism, Guillain-Barré Syndrome, neerfaha durugsan, iyo curyaannada neerfaha cranial. Kala tali bukaanka calaamadaha iyo calaamadaha suntan neerfaha, iyo dabeecadda daahday ee bilawga qaar ka mid ah suntan. Far bukaannada inay raadsadaan daryeel caafimaad degdeg ah si loo qiimeeyo iyo maarayn dheeraad ah haddii calaamadaha ama calaamadaha mid ka mid ah sunta neerfaha ay dhacaan wakhti kasta.
Guud ahaan, hal ama dhowr nooc oo hoosaadyada sunta neerfaha ee hoos lagu sharraxay ayaa dhacay ka dib ciltacabtagene autoleucel ee 26% (25/97) bukaannada, kuwaas oo 11% (11/97) bukaannada ay la kulmeen Fasalka 3 ama dhacdooyin ka sarreeya. Noocyadan hoose ee sunta neerfaha ayaa sidoo kale lagu arkay laba daraasadood oo socda.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Bukaannada waxaa laga yaabaa inay la kulmaan ICANS dilaa ah ama nafta halis gelisa ka dib daawaynta CARVYKTI®, oo ay ku jiraan ka hor inta uusan CRS bilaaban, oo la socota CRS, ka dib xallinta CRS, ama maqnaanshaha CRS. ICANS waxay ku dhacday 23% (22/97) bukaanada helaya ciltacabtagene autoleucel oo ay ku jiraan Fasalka 3 ama 4 dhacdooyinka 3% (3/97) iyo Fasalka 5 (dhimasho) dhacdooyinka 2% (2/97). Waqtiga dhexdhexaadka ah ee bilawga ICANS wuxuu ahaa 8 maalmood (qiyaastii 1-28 maalmood). Dhammaan 22 bukaan ee qaba ICANS waxay qabeen CRS. Muujinta ugu badan (≥5%) ee ICANS waxaa ka mid ah encephalopathy (23%), aphasia (8%) iyo madax xanuun (6%).
La soco bukaanka ugu yaraan maalin kasta 10 maalmood ka dib CARVYKTI® faleebo laga helo xarunta daryeelka caafimaadka ee REMS ee calamadaha iyo calaamadaha ICANS. Meesha ka saar sababaha kale ee calaamadaha ICANS. La soco bukaanada calaamadaha ama calaamadaha ICANS ugu yaraan 4 usbuuc ka dib faleebo oo si degdeg ah u daaw. Sunta neerfaha waa in lagu maareeyaa daryeel taageero ah iyo/ama corticosteroids haddii loo baahdo.
Parkinsonism: Bukaannada 25 ee cilmi-baarista CARTITUDE-1 ee la kulma neurotoxicity, shan bukaan oo lab ah ayaa lahaa sunta neerfaha oo leh calaamado iyo calaamado dhowr ah oo Parkinsonism ah, oo ka duwan habka difaaca jirka ee unugyada neurotoxicity syndrome (ICANS). Sunta neerfaha ee leh Parkinsonism ayaa lagu soo warramey tijaabooyinka kale ee socda ee ciltacabtagene autoleucel. Bukaanadu waxay lahaayeen calaamado Parkinsonian iyo non-parkinsonian ah oo ay ku jiraan gariir, bradykinesia, dhaqdhaqaaqa aan ikhtiyaarka lahayn, stereotypy, luminta dhaq-dhaqaaqa kediska ah, waji daboolan, dareen la'aan, saameyn siman, daal, qallafsanaan, dib u dhac maskaxeed, micrographia, dysgraphia, apraxia, caajisnimo, wareer, somnoloji , miyir beelka, dib-u-celinta dib-u-celinta, hyperreflexia, xusuusta lumis, liqitaanka oo adkaata, saxaro la'aanta, hoos u dhaca, qaabka foorarsan, socodka socodka, daciifnimada murqaha iyo luminta, dhaqdhaqaaqa dhaqdhaqaaqa, dhaqdhaqaaqa dhaqdhaqaaqa iyo dareenka luminta, miyir-beelka akinetic, iyo calamadaha sii daaya xudunta hore. Dhexdhexaadinta bilawga parkinsonism-ka ee bukaannada 5 ee ku jira CARTITUDE-1 waxay ahayd 43 maalmood (qiyaastii 15-108) laga soo bilaabo faleebo ciltacabtagene autoleucel.
La soco bukaanada calaamadaha iyo calaamadaha Parkinsonism ee laga yaabo in ay daahiyaan bilawga oo lagu maareeyo tallaabooyin daryeel taageero ah. Waxaa jira xog waxtar leh oo xaddidan oo leh dawooyinka loo isticmaalo daawaynta cudurka Parkinson, hagaajinta ama xallinta calaamadaha Parkinsonism ka dib CARVYKTI® Daaweynta.
Guillain-Barré Syndrome: Natiijo dilaa ah oo daba socota Guillain-Barré Syndrome (GBS) ayaa ku dhacday daraasad kale oo socota oo ku saabsan ciltacabtagene autoleucel in kasta oo lagu daaweeyay immunoglobulins xididada. Calaamadaha la soo sheegay waxaa ka mid ah kuwa la socda kala duwanaanshaha Miller-Fisher ee GBS, maskaxda, daciifnimada dhaqdhaqaaqa, qaska hadalka iyo polyradiculoneuritis.
La soco GBS Qiimee bukaanada soo bandhigaya neuropathy durugsan ee GBS. Tixgeli daaweynta GBS oo leh cabbiro daryeel taageero iyo iyadoo lala kaashanayo immunoglobulins iyo beddelka balaasmaha, iyadoo ku xiran darnaanta GBS.
Peripheral Neuropathy: Lix bukaan oo ku jira CARTITUDE-1 ayaa sameeyay neuropathy peripheral. Neuropathy-yadan ayaa loo soo bandhigay sida dareenka, dhaqdhaqaaqa ama dareemayaasha dareemayaasha. Waqtiga dhexdhexaadka ah ee bilawga calaamaduhu wuxuu ahaa 62 maalmood (qiyaastii 4-136 maalmood), muddada dhexdhexaadka ah ee neuropathy durugsan waxay ahayd 256 maalmood (qiyaastii 2-465 maalmood) oo ay ku jiraan kuwa qaba neuropathy socda. Bukaan-socodka la kulmay neuropathy-ka durugsan waxay sidoo kale la kulmeen curyaan neerfaha cranial ama GBS tijaabooyin kale oo socda ee ciltacabtagene autoleucel.
Cranial Neve Palsies: Saddex bukaan (3.1%) waxay la kulmeen curyaan neerfaha cranial ee CARTITUDE-1. Dhammaan saddexda bukaan waxay lahaayeen curyaan neerfaha cranial 7; Hal bukaan ayaa sidoo kale lahaa 5aad neerfayaasha cranial palsy sidoo kale. Waqtiga dhexdhexaadka ah ee bilawga ah wuxuu ahaa 26 maalmood (qiyaastii 21-101 maalmood) ka dib faleebo ciltacabtagene autoleucel. Dhacdada 3aad iyo 6aad ee curyaanka neerfaha cranial, laba-geesoodka 7-da neerfaha cranial palsy, ka sii darida neerfaha dareemaha ka dib hagaajinta, iyo dhacdooyinka neuropathy peripheral neuropathy ee bukaanada qaba curyaanka neerfaha cranial ayaa sidoo kale lagu soo warramey tijaabooyinka socda ee ciltacabtagene autoleucel. Kala soco bukaanka calaamadaha iyo calaamadaha curyaannada neerfaha cranial. Tixgeli maaraynta corticosteroids habaysan, taas oo ku xidhan darnaanta iyo horumarka calaamadaha iyo calaamadaha.
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Fatal HLH waxay ku dhacday hal bukaan (1%), 99 maalmood kadib ciltacabtagene autoleucel. Dhacdada HLH waxaa ka horreeyay CRS oo soconaysa 97 maalmood. Calaamadaha HLH/MAS waxaa ka mid ah hypotension, hypoxia oo leh dhaawaca alveolar fidsan, coagulopathy, cytopenia, iyo hawlgabka xubnaha badan, oo ay ku jiraan cillad kelyaha. HLH waa xaalad nafta halis gelisa oo leh heer dhimasho oo sarreeya haddii aan la aqoonsan oo aan goor hore la daweyn. Daaweynta HLH/MAS waa in lagu maamulaa halbeegyada hay'adaha.
CARVYKTI® REMSSababtoo ah khatarta CRS iyo sunta neerfaha, CARVYKTI® waxa kaliya oo lagu heli karaa barnaamijka xaddidan ee hoos yimaada Qiimaynta Khatarta iyo Istaraatiijiyada Yaraynta (REMS) ee loo yaqaan CARVYKTI® REMS
CYTOPENIAS RAACSAN OO SOO NOQDABukaan-socodka ayaa laga yaabaa inay muujiyaan cytopenia daba-dheeraaday oo soo noqnoqda ka dib lymphodepleting chemotherapy iyo CARVYKTI® faleebo. Hal bukaan ayaa lagu sameeyay daawaynta unugyada asliga ah ee dib u habeynta hematopoietic sababtoo ah trombocytopenia oo dheer.
CARTITUDE-1, 30% (29/97) bukaanada waxay la kulmeen Fasalka 3 ama 4 neutropenia oo daba dheeraaday iyo 41% (40/97) bukaanada waxay la kulmeen Fasalka 3 ama 4 thrombocytopenia oo daba dheeraaday oo aan la xalin maalinta 30 ka dib faleebo cittacabtagene autoleucel.
Fasalka 3 ama 4 ee soo noqnoqda neutropenia, thrombocytopenia, lymphopenia iyo dhiig-yaraan ayaa lagu arkay 63% (61/97), 18% (17/97), 60% (58/97), iyo 37% (36/97) ka dib markii ay ka soo kabteen Fasalka hore ee 3 ama 4 cytopenia ka dib faleebo. Ka dib Maalinta 60 ee ka dib faleebo ciltacabtagene autoleucel, 31%, 12% iyo 6% bukaanada ayaa soo noqday Fasalka 3 ama ka sareeya lymphopenia, neutropenia iyo trombocytopenia, siday u kala horreeyaan, ka dib markii ay soo kabsadeen Fasalka 3 ama 4 cytopenia. Boqolkiiba siddeetan-toddobo (84/97) bukaannada ayaa hal, laba, ama saddex ama in ka badan ku soo noqday Fasalka 3 ama 4 cytopenia ka dib markii ay ka soo kabteen fasalka 3 ama 4 cytopenia. Lix iyo 11 bukaan waxay qabeen Fasalka 3 ama 4 neutropenia iyo thrombocytopenia, siday u kala horreeyaan, wakhtiga dhimashada.
La soco tirooyinka dhiigga ka hor iyo ka dib CARVYKTI® faleebo. Maamul cytopeniyas leh arrimo koritaan iyo taageerada ku shubista wax soo saarka dhiigga sida waafaqsan tilmaamaha hay'adaha maxalliga ah.
CADAALADAHA: CARVYKTI® waa in aan la siin bukaanka qaba caabuq firfircoon ama xanuunada bararka. Infekshanno daran, nafta halis gelinaya ama dilaa ah ayaa ku dhacay bukaannada ka dib CARVYKTI® faleebo.
Caabuqa (dhammaan darajooyinka) ayaa ku dhacay 57 (59%) bukaan. Fasalka 3 ama 4 caabuqa ayaa ku dhacay 23% (22/97) bukaanada; Fasalka 3 ama 4 infekshannada cudur-sidaha aan la cayimin ayaa ku dhacay 17%, caabuqyada fayraska ee 7%, caabuqyada bakteeriyada 1%, iyo caabuqyada fungal ee 1% bukaannada. Guud ahaan, afar bukaan ayaa qabay caabuqyada Fasalka 5: sambabada sambabada (n=1), sepsis (n=2) iyo oof-wareenka (n=1).
La soco bukaanka calaamadaha iyo calaamadaha caabuqa ka hor iyo ka dib CARVYKTI® faleebo oo u daawee bukaanka si habboon. Maamul ka hortag, ka-hortag iyo/ama ka-hortagga-ka-hortagga-ka-hortagga ee ku-daweynta sida waafaqsan hab-raacyada hay'adaha caadiga ah. Febrile neutropenia ayaa lagu arkay 10% bukaanada ka dib faleebo ciltacabtagene autoleucel, waxaana laga yaabaa inay la socoto CRS. Haddii ay dhacdo qandho neutropenia, qiimee caabuqa oo ku maareyso antibiyootiga ballaaran, dareeraha iyo daryeelka kale ee taageerada, sida caafimaad ahaan lagu tilmaamay.
Dib-u-kicinta Fayraska: Fayraska cagaarshow B (HBV) dib-u-kicinta, xaaladaha qaarkood oo keena cagaarshow buuxa, beer-xumo iyo dhimasho, waxay ku dhici kartaa bukaannada qaba hypogammaglobulinemia. Samee baaritaanka Cytomegalovirus (CMV), HBV, fayraska cagaarshow C (HCV), iyo fayraska difaaca jirka (HIV), ama wax kasta oo kale oo cudur ah haddii kiliinikada lagu tilmaamo si waafaqsan tilmaamaha kiliinikada ka hor inta aan la ururin unugyada wax soo saarka. Tixgeli daawaynta ka hortagga fayraska si looga hortago dib-u-kicinta fayraska marka loo eego tilmaamaha hay'adaha maxalliga ah/dhaqanka caafimaad.
HYPOGAMMAGLOBULINEMIA waxaa lagu soo warramey inay tahay dhacdo xun 12% (12/97) bukaanada; Heerarka shaybaarka IgG ayaa hoos uga dhacay 500 mg/dL ka dib faleebo 92% (89/97) bukaannada. La soco heerarka immunoglobulin ka dib daawaynta CARVYKTI® oo maamul IVIG ee IgG <400 mg/dL. Maamul habraacyada hay'adaha maxalliga ah, oo ay ku jiraan taxaddarrada caabuqa iyo antibiyootiga ama ka hortagga fayraska.
Isticmaalka Tallaalka Nool: Badbaadada tallaalka fayraska nool inta lagu jiro ama raacaya CARVYKTI® daawaynta lama baran. Tallaalka fayraska nool laguma talinayo ugu yaraan 6 toddobaad ka hor bilowga daaweynta kemotherabi ee lymphodepleting, inta lagu jiro CARVYKTI® daawaynta, iyo ilaa soo kabashada difaaca ka dib daawaynta CARVYKTI®.
FICILYADA HOOSEYADA ku dhacay 5% (5/97) bukaanada ka dib faleebo ciltacabtagene autoleucel. Dareen-celinta xasaasiyadda daran, oo ay ku jirto anaphylaxis, ayaa laga yaabaa inay sabab u tahay dimethyl sulfoxide (DMSO) ee CARVYKTI®. Bukaan-socodka waa in si taxadar leh loola socdo 2 saacadood ka dib faleebo si loo ogaado calaamadaha iyo calaamadaha falcelinta daran. Si degdeg ah u daawee oo si habboon u maareey iyadoo loo eegayo darnaanta falcelinta xasaasiyadda.
DHIBAATOOYINKA LABAAD: Bukaan-socodka waxaa laga yaabaa in ay yeeshaan xumaansho labaad. La soco nolosha-dheer cudurada malignantiga ah. Haddii ay dhacdo in xumada labaad ay dhacdo, la xidhiidh Janssen Biotech, Inc., at 1-800-526-7736 si aad uga warbixiso iyo si aad u hesho tilmaamo ku saabsan ururinta shaybaarada bukaanka si loogu baadho xumaanta labaad ee asalka unugga T.
SAAMAYNTA AWOODDA LAGU WADA KARO IYO ISTICMAALKA MAKIINADA: Sababo la xiriira suurtagalnimada dhacdooyinka neerfaha, oo ay ku jiraan xaalad maskaxeed oo isbeddelay, qalal, hoos u dhaca neurocognitive, ama neuropathy, bukaanku waxay halis ugu jiraan isbeddelka ama hoos u dhaca miyirka ama isuduwidda toddobaadyada 8 ee ka dambeeya CARVYKTI® faleebo. Kula tali bukaanada inay ka waantoobaan wadista oo ay ku lug yeeshaan shaqooyinka khatarta ah ama hawlaha, sida ku shaqaynta mishiinada culus ama khatarta ah muddadan bilowga ah, iyo haddii ay dhacdo bilawga cusub ee sunta neerfaha.
LACAG LA'AAN AH
Dareen-celinta xun ee ugu badan ee aan shaybaarka ahayn (dhacdooyinka ka badan 20%) waa pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, murqo xanuun, daal, caabuqa pathogene aan la cayimin, qufac, qarqaryo, shuban, lallabbo, maskaxda, hoos u dhaca rabitaanka cuntada, sare. caabuqa neef-mareenka, madax-xanuun, tachycardia, dawakhaad, dyspnea, barar, caabuq fayras ah, xinjirowga dhiigga, calool-istaagga, iyo matag. Dareen-celinta xun ee shaybaadhka ugu caansan (dhacdooyinka ka weyn ama la mid ah 50%) waxaa ka mid ah thrombocytopenia, neutropenia, dhiig-yaraan, sare u qaadida aminotransferase, iyo hypoalbuminemia.
Daaweynta T-Cell-ka Baabuurka Waxay ka mid tahay daawaynta horumarsan ee noocyada kansarka dhiigga qaarkood. Waxa socda in ka badan 750 tijaabada caafimaadka in CAR T-Cell daaweynta Shiinaha hadda. Bukaanka raba in ay isdiiwaangeliyaan way la soo xidhiidhi karaan Faa'iidada Kansarka Khadka caawinta bukaanka ee WhatsApp + 91 96 1588 1588 ama emayl ku soo dir info@cancerfax.com.
Fadlan si buuxda u akhri Qorista Macluumaadka oo ay ku jirto Digniinta Sanduuqa ee CARVYKTI®.
KU SAABSAN CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel waa BCMA ay hagto, hidde ahaan wax laga beddelay autologous T-cell immunotherapy, taas oo ku lug leh dib u habaynta unugyada T-unugyada bukaanka oo leh transgene codeing a chimeric antigen reseptor (CAR) kaas oo tilmaamaya oo tirtiraya unugyada muujiya BCMA. BCMA waxaa ugu horrayn lagu muujiyaa dusha sare ee unugyada laynka B-myeloma malignant, iyo sidoo kale unugyada dambe ee B-unugyada iyo unugyada balaasmaha. Borotiinka cilta-cel CAR wuxuu leeyahay laba unugyada difaaca jirka ee BCMA-bartilmaameedka ah oo loogu talagalay in lagu bixiyo caafimad sare oo ka dhan ah BCMA aadanaha. Marka lagu xiro unugyada BCMA-muujinta, CAR waxay kor u qaadaa firfircoonida unugyada T-unugga, ballaarinta, iyo baabi'inta unugyada bartilmaameedka ah.[1]
Bishii Disembar 2017, Legend Biotech waxay la gashay shati caalami ah oo gaar ah iyo heshiis iskaashi Janssen Biotech, Inc.
Bishii Febraayo 2022, cilta-cel waxa ansixisay Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) iyada oo hoos imanaysa magaca sumadda CARVYKTI® ee daawaynta dadka waaweyn ee qaba labakaclayn ama soo noqnoqda myeloma. Bishii Maajo 2022, Komishanka Yurub (EC) waxay siiyeen oggolaanshaha suuqgeynta shuruudda ah ee CARVYKTI® ee daawaynta dadka qaangaarka ah ee soo noqnoqda iyo dib u celinta myeloma badan.[3] Bishii Sebtembar 2022, Wasaaradda Caafimaadka, Shaqada iyo Daryeelka ee Japan (MHLW) ayaa ansixisay CARVYKTI®.[4] Cilta-cel waxa la siiyay Magacaabista Daawaynta Breakthrough ee Maraykanka Diisambar 2019 iyo Shiinaha Agoosto 2020. Intaa waxaa dheer, cilta-cel waxay heshay daawaynta mudnaanta leh ee Komishanka Yurub Abriil 2019. Cilta-cel sidoo kale waxay heshay Dawooyinka Agoonta ah. Magacaabid ka timid FDA US bishii Febraayo 2019, oo ka timid Komishanka Yurub Febraayo 2020, iyo Hay'adda Dawooyinka iyo Dawooyinka (PMDA) ee Japan Juun 2020. Bishii Maarso 2022, Guddiga Wakaaladda Daawooyinka Yurub ee Agoonta Alaabada Daawooyinka ayaa lagu taliyay iyadoo la isku raacsan yahay. in agoonta agoonta ee cilta-cel lagu hayo iyadoo lagu salaynayo xogta caafimaad ee muujinaysa heerka jawaab celinta dhamaystiran ee soo hagaagtay iyo joogtaynta ka dib daaweynta.
KU SAABSAN MYELOMA BADAN
Multiple myeloma is an incurable kansarka dhiigga that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.[8] Although treatment may result in remission, unfortunately, patients will most likely relapse. Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.
[1] CARVYKTI™ Macluumaadka Qorista. Horsham, PA: Janssen Biotech, Inc.
[2] CARVYKTI ™ (ciltacabtagene autoleucel), BCMA-Hagaha CAR-T Therapy, Heshay Oggolaanshaha FDA US ee Daaweynta Bukaannada Qaangaarka ah ee qaba Myeloma badan oo soo noqnoqday ama dib u celinaya. Waxaa laga heli karaa: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-bcma-directed-car-t-therapy-receives-us-fda-approval-for-the-treatment-of-adult-patients -oo-la-soo-noqoshada-ama-soo-celinta-multiple-myeloma/. La galay Oktoobar 2022.
[3] CARVYKTI (ciltacabtagene autoleucel) Ansixinta Shuruudaha ah ee la siiyay Guddiga Yurub ee Daaweynta Bukaannada Soo noqnoqda iyo Dib-u-celinta Multiple Myeloma. Waxaa laga heli karaa: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-granted-conditional-approval-by-the-european-commission-for-the-treatment-of-patients-with-relapsed-iyo Dib-u-celinta-multiple-myeloma/. La galay Oktoobar 2022.
[4] CARVYKTI ™ (ciltacabtagene autoleucel) Waxay Oggolaanshaha ka heshaa Wasaaradda Caafimaadka Japan, Shaqada iyo Samafalka (MHLW) ee daawaynta Bukaannada qaba Myeloma-ka-soo-kabashada ama dib-u-soo-kabashada. Waxaa laga heli karaa: https://www.businesswire.com/news/home/20220926005847/en/CARVYKTI%E2%84%A2-ciltacabtagene-autoleucel-Receives-Approval-from-Japan%E2%80%99s-Ministry-of -Caafimaadka-Shaqada-iyo-Caafimaadka-MHLW-daawaynta-Bukaan-socod-ama-Dib-u-soo-celinta-Multiple-Myeloma. La galay Oktoobar 2022.
[5] Komishanka Yurub. Diiwaanka Bulshada ee Agabka Agoonta. Waxaa laga heli karaa: https://ec.europa.eu/health/documents/community-register/html/o2252.htm. La galay Oktoobar 2022.
[6] Bulshada Maraykanka ee Oncology Clinic. Multiple myeloma: hordhac. https://www.cancer.net/cancer-types/multiple-myeloma/introduction. La galay Oktoobar 2022.
[7] Ururka Kansarka Mareykanka. "Tirakoobka Muhiimka ah ee ku saabsan Multiple Myeloma." Waxaa laga heli karaa: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relationly,men%20and%2015%2C370% 20% 20 haween ah). La galay Janaayo 2023.
[8] Ururka Kansarka Mareykanka. Myeloma badan: ogaanshaha hore, ogaanshaha iyo diyaarinta. https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. La galay Oktoobar 2022.
[9] Rajkumar SV. Multiple myeloma: Cusboonaysiinta 2020 ee ogaanshaha, khatarta-saaridda iyo maaraynta. Waxaan ahay J Hematol. 2020;95 (5),548-567. doi:10.1002/ajh.25791.
[10] Kumar SK, Dimopoulos MA, Kastritis E, iyo al. Taariikhda dabiiciga ah ee myeloma soo noqnoqda, u diida daawooyinka immunomodulatory iyo proteasome inhibitors: daraasad IMWG ah oo badan. Leukemia. 2017;31 (11):2443- 2448.
[11] Gandhi UH, Cornell RF, Lakshman A, iyo al. Natiijooyinka bukaannada qaba myeloma-da badan ee u diida CD38-ku-daawaynta antibody-ka monoclonal-ku wajahan. Leukemia. 2019;33 (9):2266-2275.
KU SAABSAN LEGEND BIOTECH
Legend Biotech waa shirkad caalami ah oo bayooloojiyada bayoolajiga ah oo u heellan in ay daweyso, iyo maalin ay daaweyso cudurrada nafta halis geliya. Xarunteedu tahay Somerset, New Jersey, waxaanu horumarinaynaa daawayn unug horumarsan oo ka kooban noocyo kala duwan oo tignoolajiyadeed, oo ay ku jiraan autologous iyo allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) iyo dilaaga dabiiciga ah (NK) unug ku salaysan immunotherapy. Laga soo bilaabo seddexda goobood ee R&D ee adduunka, waxaan ku dabaqnaa tignoolajiyadan cusub si aan u daba galno helitaanka daawaynta badbaadada, waxtarka leh iyo goynta ee bukaannada adduunka oo dhan.
