Hona joale re khona ho tsosolosa 'mele ea rona
FDA e amohetse phekolo ea kalafo ea liphatsa tsa lefutso ka lekhetlo la pele-phetoho ea histori historing ea bongaka. Phekolo e ncha- Kymriah (tisagenlecleucel) -se e fetotse T-cell ho loantša kankere ea mali.
Kamohelo ea Kymriah e sebetsa e le pontšo ea tumello ea mekhoa e meng ea phekolo ea liphatsa tsa lefutso e tla loantša kankere le maloetse a mang a tebileng a sebelisa tsela e ncha le e thahasellisang: ho ruruha 'mele ka mekhoa ea maiketsetso.
Tlhahlobo ea Gene e thehiloe ka sele
Cell-based gene therapy e bua ka mokhoa oa ho kenyelletsa liphatsa tsa lefutso tse ncha ka seleng e khethehileng ebe joale o kenyelletsa lisele tsena tse fetotsoeng 'meleng. Hang ha 'meleng, lisele tsena tse ncha li ka hlahisa liprotheine tse thusang ho loantša kankere kapa maloetse a mang a tebileng.
Kymriah e akarelletsa ho kenyelletsa li-T-cell tse fetoletsoeng ka liphatsa tsa lefutso-mofuta oa lymphocyte, kapa sele e tšoeu ea mali-'meleng. Lisele tsena tsa T tse fetotsoeng li hlokomela le ho hlasela lisele tsa kankere.
Ho phekoloa ha liphatsa tsa lefutso ho molemo ho chemotherapy hobane mafu a liphatsa tsa lefutso ha a na chefo. Chemotherapy e ama 'mele oohle' me e baka liphello tse bohloko tsa 'mele. Ka cell-based gene therapy, lisele tse tsosolosoa hape li kenngoa sebakeng sa heno 'me li loantša lihlahala ka ho toba.
Ntle le ho ba mofuta oa phekolo ea liphatsa tsa lefutso, Kymriah e boetse e le moemeli oa immunotherapeutic agent. Immunotherapy leverages matla a sesole sa 'mele ea ho itšireletsa mafung.
Kymria e Hlalosoa
Ka litsebi tsa bokhoni, Novartis's Kymriah ke teko ea lisele ea T-cell e sebelisoang ho phekola ho khutla kapa ho tsuba (e leng, ho hanyetsa phekolo) B-cell acute lymphoblastic leukemia.
Kymriah ke mofuta o tloaelehileng oa immunotherapy moo lisele tsa T-meleng tsa mokuli li bokelloang pele ebe li romeloa setsing sa tlhahiso.
Lisele tsa T lia kotuloa ka mokhoa o bitsoang leukapharesis.
Setsing sa tlhahiso ea lisebelisoa, lisele tsena tsa T li fetotsoe ho kenyeletsa liphatsa tsa lefutso tse khethollang polelo ea CAR. Lisele tsena tse fetotsoeng li kenngoa hape ka mokuli. Hang ha e le 'meleng, li-CAR li lebisa ho antigen e itseng e bitsoang CD19 e fumanehang holim'a lisele tsa kankere le ho bolaea lisele tsena tsa kankere. Hang ka maling, li-T-cell tse fetotsoeng li hōla le ho atolosa ho felisa kankere nakong ea libeke tse peli kapa tse tharo.
Litsebi tsa FDA li thehile tumello ea tsona ea Kymriah ka letsoho le le leng la teko ea bobeli ea sekhahla sa bobeli sa bobeli, moo bana ba 63, ba lilemong tsa bocha le ba banyenyane ba nang le kankere ea 'mele ea B-cell ac-lymphoblastic e khutliselitsoeng kapa e tsitsitseng, ba fumanoang ka tekanyo e le' ngoe ea phekolo. Har'a batsoaruoa bana, karolo ea 83 lekholong e ile ea kenngoa morao ka mor'a likhoeli tse tharo. Ho feta moo, karolo ea 75 lekholong e ile ea lula e se na lefu ka mor'a likhoeli tse tšeletseng. Habohlokoa, Kymriah e ile ea fuoa Tlhahlobo ea Bohlokoa Pele le Tlhahlobo ea Therapy ea FDA.
Acute lymphoblastic leukemia ke kankere ea masapo le mali. E etsa hore 'mele o etse lymphocyte e sa tloaelehang. Lisele tsena tse sa tloaelehang tsa mali li potlakela ho ntša lisele tse phelang hantle 'meleng lerung. Re hloka lisele tsa mali tsa rona ho pholoha.
Ha palo ea lisele tse tloaelehileng tsa mali e fokotseha haholo, lefu le ka etsoa.
Le hoja batho ba baholo ba ka hlahisa bohle, ke haholo-holo lefu la bana. Hoo e ka bang karolo ea 90 lekholong ea bana ba nang le bohle ba kene ka mor'a ho phekoloa. Kymriah e lumelloa hore e sebelisoe ho bakuli ba ka tlaase ho lilemo tse 25 'me ba e-na le kankere e khutliselitsoeng kapa kankere e hanelang phekolo.
Ho tšoenyeha ka Kymria
E 'ngoe mabapi le phello e mpe ea mofuta leha e le ofe oa monoclonal antibody therapy ke cytokine release syndrome, e leng phetoho ea ho fokotsa metsi e bitsoang cytokine sefefo. Li-cytokine ke liprotheine tse nyenyane tse pateletsoeng ke lisele tse nang le liphello lisele tse ling.
Batho ba bangata, matšoao a cytokine release syndrome a bonolo kapa a leka-lekaneng mme a ka phekoloa habonolo. Matšoao ana a kenyelletsa:
- khatello e tlase ea mali
- mokhathala
- tachycardia
- hlooho
- feberu
- ho nyekeloa ke pelo
- ho tsuba
- rash
- 'mala o phatsimang
- khathatso ea ho phefumoloha
Leha ho le joalo, bakuli ba nang le kankere ea mali-joaloka bohle-ba kotsing e kholo ea ho ba le sefefo se matla sa cytokine le matšoao a kotsi bophelong. Ka lebaka lena, ho tšoaetsoa mafu ho hlokahala hore ho etsoe litsing tse phahameng tsa boholo-holo le litsebi tse koetliselitsoeng ho sebetsana le mathata a tebileng joaloka sefefo sa cytokine.
Qetellong, Kymria e lebeletsoe ho lefella $ 500,000. Leha ho le joalo, phekolo e nang le Kymriah e ntse e le theko e tlaase ho feta ho kenyelletsa 'mele oa masapo, oo hangata o sebelisetsoang ho phekola kankere ea mali.
Lentsoe le Tsoang ho
Ho hanyetsa kapa ho tsosolosa ALL ke lefu le bolaeang. Kamohelo ea Kymria e fana ka tšepo bakeng sa makholo a seng makae a bacha ba United States ba se nang mekhoa ea phekolo e setseng. E ipakile e sebetsa hantle litsing tsa kliniki. Leha ho le joalo, liteko tsa kliniki li ne li fokotsehile ka nako e telele, 'me e ntse e le teng ho bona hore na Kymriah e ka etsa hore ho fokotsoe bophelo bohle.
Mantsoe a hlakileng, tumello ea FDA ea mofuta oa phekolo ea liphatsa tsa lefutso ka lekhetlo la pele ka nako e ncha ea phekolo ea meriana: lilemo tseo ka tsona re ka khonang ho rera lisele tsa rona ho loantša kankere le maloetse a mang a bolaeang.
> Mehloli:
> Breslin S. Cytokine-release syndrome: tlhahiso-palo le tlhokomelo ea booki. Clinical Journal ea Oncology Nursing. 2007; 11: 37-42.
> Colwell J. Panel OKs Therapy ea T ea Lefuemia. Ho Fumana Kankere. La 27 July, 2017.
> FDA News Release. Tumelo ea FDA e tlisa phekolo ea pele ea liphatsa tsa lefutso ho United States. La 30 August, 2017.
> High KA. Gene Therapy ka Meriana ea Meriana. Ka: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Melao ea Harrison ea Meriana ea ka Hare, 19e New York, NY: Hill ea McGraw; 2014.
> Klepin HD, Powell BL. Mathata a Lisele tsa White. Ka: Halter JB, Ouslander JG, Studenski S, High KP, Asthana S, Supiano MA, Ritchie C. eds. Hazzard's Geriatric Medicine le Gerontology, 7e New York, NY: McGraw-Hill.