FDA ta amince da shirin farko na Farfesa don cutar sankarar bargo

Zamu iya sake tsara jikinmu

FDA ta amince da maganin farfado da jinsin jini a karo na farko-wani tarihin tarihi a tarihin maganin. Sabuwar magani- Kymriah (tisagenlecleucel) -us sun canza t-kwayoyin T don yaki cutar sankarar bargo.

Gwargwadon Kymriah yana aiki ne a matsayin tsinkaye don amincewa da wasu nau'in tsarin farfadowa da za su iya magance ciwon daji da sauran cututtuka masu tsanani ta hanyar amfani da matsala da mahimmanci.

Tsarin Cell-Based Gene Far

Maganin kwayar cutar ta jiki yana nufin aikin gabatar da sabon kwayoyin halitta a cikin wasu kwayoyin halitta sannan kuma sake gabatar da wadannan kwayoyin canzawa cikin jiki. Da zarar cikin jiki, wadannan kwayoyin halitta zasu iya samar da sunadaran da ke taimakawa wajen magance ciwon daji ko wasu cututtuka masu tsanani.

Kymriah ya shafi gabatarwa da kwayoyin T-tarin halitta-irin nau'in lymphocyte, ko jini mai tsabta-cikin jiki. Wadannan kwayoyin T-canza sun gane da kai farmaki kwayoyin cutar sankarar bargo.

Kullum farfesa shine mafi kyawun maganin cutar kumburi saboda ƙwayoyin warkad da kwayar cutar ba su da guba. Chemotherapy yana rinjayar jiki duka kuma yana haifar da mummunar tasirin jiki. Tare da farfadowa na tushen kwayoyin halitta, ana iya sake yin amfani da kwayoyin sarrafawa a gida kuma suna yaki da ciwon sukari musamman.

Bugu da ƙari da kasancewa nau'i na farfadowa na kwayar halitta, Kymriah ma wani wakili ne na immunotherapeutic. Immunotherapy yana amfani da ikon tsarin kulawa don magance cutar.

An bayyana Kymriah

A cikin ka'idodin fasahar, Kymriah na Novartis wani gwajin gwagwarmaya na antimetric antigetor (CAR) T-cell da aka yi amfani da shi don magance maimaitawa ko gurgunta (watau resistant zuwa magani) B-cell lymphoblastic leukemia.

Kymriah wani tsari ne na immunotherapy wanda aka tattara a jikin T-sel na mai haƙuri kuma a aika shi zuwa cibiyar masana'antu.

Ana girbe T-sel ta amfani da hanyar da ake kira leukapharesis.

A cibiyar masana'antu, ana gyaran wadannan t-tarin T don haɗawa da wata hanyar da ta yi amfani da furucin don magana ta CAR. Wadannan suturar sunadaran sun sake komawa cikin mai haƙuri. Da zarar cikin jiki, CARs ta kama wani antigen da ake kira CD19 wanda yake a kan cutar cutar sankarar bargo kuma ya kashe waɗannan kwayoyin halitta. Da zarar cikin jinin, waɗannan kwayoyin T-canza suna girma da kuma fadadawa don kawar da ciwon daji a cikin makonni biyu ko uku.

Masana a FDA sun yarda da yarda da Kymriah akan wani bangare guda na gwaji na asibiti inda yara 63, da matasa, da kuma matasan da suka sake komawa ko cutar B-cell da ke cikin lymphoblastic cutar sankarar bargo sun sami kashi daya daga cikin maganin. Daga cikin wadannan mahalarta, kashi 83 cikin dari sun shiga cikin gafara bayan watanni uku. Bugu da ƙari kuma, kashi 75 cikin 100 sun kasance marasa lafiya bayan watanni shida. Abin mahimmanci, an ba da Kymriah gabatarwa na farko da Binciken Farfesa da FDA.

Likadamusin lymphoblastic mai ɗisuwa shine ciwon daji na kasusuwa da jini. Yana sa jiki ya yi amfani da lymphocytes hauka. Wadannan ƙwayoyin jini marar hauka suna gaggauta fitar da kwayoyin jinin lafiya a cikin kututtukan kasusuwa. Muna bukatar jinin jini don mu tsira.

Lokacin da adadin ƙwayoyin jini na al'ada ya ragu sosai, mutuwa zata iya faruwa.

Ko da yake tsofaffi na iya ci gaba da DUK, shi ne magungunan yara. Kimanin kashi 90 cikin 100 na yara tare da DUG sun shiga cikin gyare-gyaren bayan magani. An amince da Kymriah don yin amfani da marasa lafiya wadanda ke da shekaru 25 da haihuwa kuma suna da ciwon daji wanda ya sake dawowa ko ciwon daji wanda ya dace da magani.

Damuwa Game da Kymriah

Ɗaya game da mummunar tasirin kowane nau'i na maganin kwayar cutar guda daya shine nakasar sarkar cytokine, wani nau'in jiko wanda ake kira cytokine hadari. Cytokines sune kananan sunadaran da aka rufe ta kwayoyin halitta kuma suna da tasiri akan sauran kwayoyin.

A mafi yawancin mutane, alamun cututtuka na suturar cytokine sun kasance mai sauƙi ko matsakaici kuma ana iya sauƙaƙe su. Wadannan bayyanar cututtuka sun haɗa da:

Duk da haka, marasa lafiya da ke da ciwon jini-kamar ALL-suna cikin haɗari mafi girma na tasowa mai tsanani na cytokine tare da rayukan bayyanar rai. Saboda haka, infusions ya kamata a faru a manyan ƙananan cibiyoyi tare da kwararru da aka horar da su don gudanar da matsaloli masu tsanani kamar cytokine hadari.

A ƙarshe, ana tsammanin Kymriah zai biya kusan $ 500,000. Duk da haka, magani tare da Kymriah har yanzu yana da rahusa fiye da suturar ɓarkewar nama, wanda aka saba amfani dashi wajen maganin cutar sankarar bargo.

Kalma Daga

Rashin banbanci ko sake komawa ALL shine cututtuka mai mutuwa. Amincewa da Kymriah yana ba da fata ga 'yan ƙananan matasa matasa a Amurka waɗanda ba su da magani. Ya tabbatar da tasiri a gwajin gwaji. Duk da haka, gwajin gwaji na da iyakance a tsawon lokaci, kuma ya kasance a gani ko Kymriah zai iya haifar da gafarar rayuwa.

A cikin cikakke kalmomi, amincewa da FDA ta hanyar jinsin farfadowa na farko don yin amfani da wani sabon zamani na maganin: shekaru ne inda za mu iya canza tsarin mu don yaki da ciwon daji da sauran cututtuka masu mutuwa.

> Sources:

> Breslin S. Cytokine-ciwon sutura: bayyanewa da kuma abubuwan da ke kula da jinya. Labarin Clinical Journal of Incology Nursing. 2007; 11: 37-42.

> Kungiyar Colwell J. OKS CAR T Tsirar cutar sankarar bargo. Cibiyar Cancer. Yuli 27, 2017.

> FDA News Release. Shirin FDA ya kawo farko ga farfadowa zuwa Amurka. Agusta 30, 2017.

> Babban KA KA. Gene Far a Clinical Medicine. A: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Ka'idodin Magunguna na Harrison, 19th New York, NY: McGraw-Hill; 2014.

> Klepin HD, Powell BL. Raunin Kwayoyin White. A: Halter JB, Ouslander JG, Studenski S, High KP, Asthana S, Supiano MA, Ritchie C. eds. Cibiyar Geriatric ta Hazzard da Gerontology, 7th New York, NY: McGraw-Hill.