Isu tinokwanisa ikozvino kudzorera miviri yedu
I-FDA yakabvumira kugadzirisa kurapwa kwemajini kwekutanga-kutama kwezvakaitika mumabhuku ezvinyorwa. Iyo mishonga -Kymriah (tisagenlecleucel) -isashandura T-seli kurwisana neukemia.
Kugamuchirwa kwaKymria kunoshanda sechibvumirano chekugamuchirwa kwemamwe marudzi emishonga inorapa iyo inorwisana nekenza uye zvimwe zvirwere zvakakomba uchishandisa nzira inoyevedza uye inonakidza: kurongedza muviri kuburikidza nenzira dzinoshandiswa.
Cell-Based Based Gene Therapy
Cell-based gene therapy inoreva mutsika wekuisa mishonga yemageneti mune imwe sero revanhu uye zvakare kuisa zvakare masero akachinjwa mumuviri. Kamwe muviri, masero matsva aya anogona kubereka mapuroteni anobatsira kurwisa kenza kana zvimwe zvirwere zvakakomba.
Kymriah inosanganisira kuiswa kwei-genetically modified T-cells-rudzi rwe lymphocyte, kana chichena cheropa ropa-mumuviri. Izvi zvakashandurwa T-seli dzinoona nekurwisa masero eukemia.
Gene therapy inonyanya kushandiswa chemotherapy nokuti maitiro ekurapa haatonyanyi kudhakwa. Chemotherapy inokanganisa muviri wose uye inoita kuti muviri wose uve nemigumisiro yakaipa. Neine-cell-based gene therapy, masero e-re-engineered akaiswa mukati maro uye anorwisana nemakumbo zvakananga.
Mukuwedzera pakuva chimiro chejena therapy, Kymriah zvakare an immunotherapeutic agent. Immunotherapy leverages simba remuviri wezvirwere zvekudzivirira zvirwere.
Kymria Anotsanangurwa
Mune manyanzvi, Novartis's Kymriah inyanzvi chimeric antigen receptor (CAR) T-cell therapy inoshandiswa kurapwa zvakare kana kuti kusagadzikana (kureva, kusagadzikana kurapwa) B-cell acute lymphoblastic leukemia.
Kymriah inzira yakagadziridzwa ye immunotherapy umo murwere weT-cell anotanga kuunganidzwa uye anotumirwa kunzvimbo yekugadzira.
I-T-masero inokohwa vachishandisa nzira inonzi leukapharesis.
Panzvimbo yekugadzira nzvimbo, idzi T-seli dzinoshandurirwa kuti dzinosanganisira geni inotanidza CAR kutaura. Aya mashandu akachinjwa anobva adzorerwa zvakare mumurwere. Rimwechete mumutumbi, CARs inotarisa imwe antigen inonzi CD19 inowanikwa pamusoro pemasero eukemia uye inouraya masero aya ane kenza. Rimwechete muropa, izvi zvakashandura T-masero zvinokura uye zvinowedzera kupedza kenza mukati memavhiki maviri kana matatu.
Nyanzvi dzeDDA dzakagamuchira chibvumirano chavo cheKymria pane imwechete yechikamu chechipiri chechipatara chekutambudzwa umo 63 vana, vechidiki, uye vechidiki vakuru vakadzoka zvakare kana kuti vanorambidza B-cell acute lymphoblastic leukemia vakagamuchira chiro chimwe chete chekurapa. Pakati pevatori vechikamu izvi, 83 muzana vakapinda mukuregererwa mushure memwedzi mitatu. Uyezve, 75 muzana vakasara vasina zvirwere mushure memwedzi mitanhatu. Zvinonyanya kukosha, Kymriah yakagamuchirwa Kudzokorora Kubudirira uye Breakthrough Therapy mazita aDFA.
Acute lymphoblastic leukemia chirwere chepafu marrow neropa. Inokonzera muviri kuti uite lymphocyte dzisina kukodzera. Aya masero eropa asingazivikanwi anokurumidza kubuda masero eropa ane utano mumusepa. Tinoda masero edu eropa kuti tirarame.
Apo nhamba yemasero evemazuva ese eropa inoderera zvishoma, rufu runogona kugadziriswa.
Kunyange vanhu vakuru vakwegura vanogona kukura Zvose, inonyanya kurwara kwevana. Vanenge 90 muzana yevana vane ALL vanoenda mukuregererwa mushure mekurapa. Kymria inogamuchirwa kuti ishandiswe kune varwere vari vaduku vanopfuura makore makumi maviri nemashanu uye vane kenza yakadzoka kana kenza iyo isingadi kurapwa.
Kunetseka Pamusoro paKymriah
Imwe pamusoro pemafungiro akaipa emhando ipi zvayo yemhando ipi neipi ye monoclonal antibody therapy inonzi cytokine release syndrome, inonzi infusion reaction inonziwo cytokine dutu. Cytokines mapurotini maduku akavanzwa nemasero uye ane matambudziko pane mamwe masero.
Muvanhu vazhinji, zviratidzo zve cytokine release syndrome zvinyoro kana zvisinganzwisisiki uye zvinogona kutorwa nyore nyore. Zviratidzo izvi zvinosanganisira:
- low blood pressure
- kuneta
- tachycardia
- headache
- fever
- nausea
- chills
- mapundu
- kupenya kwehuro
- kunetseka kufema
Zvisinei, varwere vane kenza yeropa-yakafanana neIYE-vari pangozi yakakwirira yekukurira zvakasimba cytokine dutu nemararamiro anotyisa. Nokuda kwechikonzero ichi, kuvhiringidzika kunoda kuitika panzvimbo dzakakwirira-guru nenyanzvi dzakadzidziswa kugadzirisa zvinetso zvakakomba se cytokine dutu.
Pakupedzisira, Kymriah inotarisirwa kutengesa madhora 500 000. Kunyange zvakadaro, kurapwa neKymriah kuchiri kudhura kudarika kupfurikidza kwemapfupa ekucherwa kwemafuta, ayo anowanzoshandiswa pakurapa kweukwemia.
Shoko Rinobva
Kunyengedza kana kudzokazve ZVOSE chirwere chinouraya. Kugamuchirwa kwaKymria kunopa tariro kune mazana mashomanana vechidiki muUnited States vasina nzira dzokurapa dzakasara. Yakaratidza kuti inoshanda mumakiriniki miedzo. Zvisinei, makiriniki maedzo akanga asingagumi kwenguva refu, uye inoramba ichionekwa kana Kymriah inogona kukonzera kusununguka kweupenyu hwose.
Muchidimbu, kugamuchirwa naRDA kwechimiro chejena therapy kwenguva yekutanga inoshandisa muzera idzva remishonga: zera ratinokwanisa kutorazve masero edu kurwisa kenza uye dzimwe zvirwere zvinouraya.
> Sources:
> Breslin S. Cytokine-release syndrome: kuongorora uye kuporesa zvinokonzera. Clinical Journal of Oncology Nursing. 2007; 11: 37-42.
> Colwell J. Panel OKs CAR T Therapy yeAukemia. Cancer Discovery. July 27, 2017.
> FDA News Release. FDA inogamuchirwa inounza kutanga kugadzirisa zvirwere kuUnited States. August 30, 2017.
> High KA. Gene Therapy mu Clinical Medicine. Muna: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e New York, NY: McGraw-Hill; 2014.
> Klepin HD, Powell BL. White Cell Disorders. Mu: Halter JB, Ouslander JG, Studenski S, High KP, Asthana S, Supiano MA, Ritchie C. eds. Hazzard's Geriatric Medicine uye Gerontology, 7e New York, NY: McGraw-Hill.