Izidakamizwa zakamuva ekwelapheni umdlavuza

Julayi 2021: Hlola izidakamizwa zakamuva ekwelapheni umdlavuza. Njalo ngonyaka, ngemva kokuhlola izilingo nezinye izici ezibalulekile, i USFDA ugunyaza izidakamizwa, futhi ngaleyo ndlela iziguli ezinomdlavuza manje zingakholelwa ukuthi ikhambi seliseduze kakhulu.

Eminyakeni yamuva nje, kuningi okwenzekile ukushintsha indlela lesi sifo esiyiyo nesizophathwa ngayo. Ngenxa yalokho, abantu abanomdlavuza kanye nabelaphi babo banezinketho eziningi abangakhetha kuzo nokunye okuningi endleleni.

Bheka: Izindleko zokwelashwa komdlavuza eNdiya

Amandla amangqamuzana akho okubalekela amasosha akho omzimba angenye yezinto ezenza ukulwa nomdlavuza kube inselele. Umzimba wakho awuziboni njengezinsongo, noma awukwazi nje ukusebenza ukulwa nazo kanzima ngokwanele.

Kodwa lawa mangqamuzana “amakwa” yimithi ethile yesimanje ye-immunotherapy, ngakho kulula ukuyithola. Le mithi ingenza futhi izivikelo zomzimba wakho zibe namandla ukuze zikwazi ukuhlasela izimila.

Lolu hlobo lokwelapha seluvele lusebenza ngempumelelo ezinhlotsheni ezithile zomdlavuza. Imithi eminingi eminingi iyasebenza.

Uhlobo lokwelashwa kofuzo olubizwa ngokuthi Ukwelashwa kwe-CAR T-cell ivunyelwe yi FDA. Isebenzisa amanye amaseli akho omzimba ukwelapha umdlavuza wakho, obizwa ngama-T cell. Ngokufaka izakhi zofuzo ezintsha, odokotela bakhipha amangqamuzana egazini lakho bawaguqule ukuze bakwazi ukubona nokubhubhisa amangqamuzana omdlavuza ngokushesha.

Bheka: Izindleko zokwelashwa kwe-CAR T-cell ye-acute lymphoblastic leukemia (ALL) kwa-Israel

Isidakamizwa esibizwa nge-tisagenlecleucel (Kymriah) okwamanje sigunyazwe ukwelapha i-B-cell acute lymphoblastic leukemia ezinganeni nasebancane abadala abafika eminyakeni engu-25 abangazange bathuthuke ngezinye izindlela zokwelapha. Kepha kubantu abadala kanye nezinye izinhlobo zomdlavuza, ososayensi basebenza ekwelashweni kwe-CAR T-cell.

I-Tisagenleucel ne-axicabtagene (Yescarta) zombili zigunyazwe ukwelapha ezinye izinhlobo ze-B-cell lymphoma yabantu abadala ezinye izindlela zokwelapha ezingakwazanga ukuzisiza.

Bheka: Izindleko zokwelashwa kwe-CAR T-cell e-China

Ukwelashwa okusha okubizwa I-brexucabtagene autoleucel (Tecartus) muva nje egunyazwe yi-FDA ezigulini ezine-mantle cell lymphoma abangakathuthuki ngezinye izindlela zokwelapha noma ababuye ngemva kokwelashwa.

Umdlavuza useyimpicabadala engaxazululiwe, futhi ososayensi, odokotela, nezinkampani emhlabeni wonke basafuna ukuthola ikhambi elingcono kakhulu lalesi sifo esibulalayo. Njengamanje, i-chemotherapy ingelinye lamathuluzi asebenza kahle kakhulu ezandleni zochwepheshe bomdlavuza eNdiya nasemhlabeni wonke, okuthi uma betholakala kusenesikhathi, bakwazi ukulwa nalesi sifo ngezinga elikhulu. Sibone imithi eminingi emisha iphuma eminyakeni embalwa edlule ukulwa namaseli omdlavuza. Lokhu futhi kudinga ukwelashwa okuqondisiwe okuhloswe ukuhlasela amaseli ngokuqondile, okuvumela amaseli avamile ukuthi ezwe umonakalo omncane. I-USFDA iphinde yagunyaza ukugunyazwa kwayo kokuqala kokwelashwa kokuguqula izakhi zofuzo kulo nyaka ngo-2017, iguqule ama-t cell eziguli ukuze isebenze kangcono ekulweni nomdlavuza.

Ngo-2017, i-USFDA yanikeza imvume yeminye yemithi ekholelwa ukuthi izokwenza umehluko omkhulu ekwelapheni umdlavuza. Kunjalo:

1. I-Bavencio (Avelumab) - Umdlavuza wesinye
2. Kisqali (Ribociclib) – Umdlavuza webele
3. I-Nerlynx (Neratinib) - Umdlavuza webele
4. Rydapt (Midostaurin) - Umdlavuza wegazi
5. Besponsa (Inotuzumab Ozagamicin) - Ileukemia
6. I-Kymriah (Tisagenlecleucel) - Umdlavuza wegazi
7. Tafinlar (Dabrafanib) – Umdlavuza wamaphaphu
8. IMekinist (Trametinib) - Umdlavuza wamaphaphu
9. I-Opdivo (Livolumab) - Umdlavuza wesibindi
10. I-Yescarta (Axicabtagene ciloleucel) - iLymphoma
11. I-Calquence (i-Acalabrutunib) - iLymphoma
12. IBavencio (Avelumab) - Merkel cell carcinoma
13. UZejula (Niraparib) - Umdlavuza we-Ovarian
14. I-Keytruda (Pembrolizumab) - Umdlavuza wesisu