Izinkomba ezintsha nezibuyekeziwe zigunyazwe yi-FDA ye-temozolomide ngaphansi kwe-Project Renewal

Izinkomba ezintsha nezibuyekeziwe zigunyazwe yi-FDA ye-temozolomide ngaphansi kwe-Project Renewal
I-Food and Drug Administration (FDA) igunyaze ukulebula okubuyekeziwe kwe-temozolomide (Temodar, Merck) ngaphansi kwe-Project Renewal, i-Oncology Center of Excellence (OCE) isinyathelo esihloselwe ukubuyekeza imininingwane yokulebula yemithi emidala ye-oncology ukuze kuqinisekiswe ukuthi ulwazi lubalulekile ngokomtholampilo futhi luthuthukisiwe ngokwesayensi- kuze kube manje. Lona umuthi wesibili wokuthola isibuyekezo sokulebula ngaphansi kwalolu hlelo lokuhlola. Umuthi wokuqala owathola ukugunyazwa ngaphansi kweProjekthi Yokuvuselela kwakuyi-capecitabine (Xeloda).

Yabelana ngalokhu okuthunyelwe

Nov 2023: Ngaphansi kweProjekthi Yokuvuselela, uhlelo lwe-Oncology Centre of Excellence (OCE) okuhloswe ngalo ukubuyekeza imininingwane yokulebula emithini emidala ye-oncology ukuze kuqinisekiswe ukuthi ulwazi lubalulekile ngokomtholampilo futhi luhambisana nesikhathi ngokwesayensi, iFood and Drug Administration (FDA) igunyaze ukulebula okubuyekeziwe kwe-temozolomide ( Temodar, Merck). Ngaphansi kwalolu hlelo lokuhlola, lona umuthi wesibili ukuthi ilebula yawo ibuyekezwe. I-Capecitabine (Xeloda) kwaba imithi yokuqala egunyazwe ngaphansi kwe-Project Renewal.

Ngemizamo ehlanganyelwe yokuvuselelwa kweProjekthi, ososayensi abasakhula kanye nongoti be-oncology bangaphandle bahlaziya izincwadi ezishicilelwe ukuze bathole ulwazi mathupha ekukhetheni, ekulungiseni nasekuhlolweni kwedatha yokubuyekezwa kwe-FDA ezimele. Umgomo Wokuvuselelwa Kwephrojekthi uwukugcina ukulebula kwakamuva kakhulu kwemithi ye-oncology emidala, evame ukunikezwa kuyilapho kukhulisa ulwazi lomphakathi lokulebula izidakamizwa njengomthombo wolwazi futhi kunikeze ukuvuleka kwezidingo zobufakazi ze-FDA kanye nenqubo yokuhlola.

I-Temozolomide manje isivunyelwe kulezi zinkomba ezintsha nezibuyekeziwe ezilandelayo:

  • ukwelashwa kwe-adjuvant kwabantu abadala abane-anaplastic astrocytoma esanda kutholakala.
  • ukwelashwa kwabantu abadala abane-refractory anaplastic astrocytoma.

Inkomba eyodwa evunyelwe ye-temozolomide isafana:

  • ukwelashwa kwabantu abadala abane-glioblastoma esanda kutholakala, kanye ne-radiotherapy bese kuba njengokwelashwa kwesondlo.

Izibuyekezo zokulebula ezengeziwe zifaka:

  • Umuthi wemithamo uyabuyekezwa futhi ubuyekezelwe i-glioblastoma esanda kutholwa kanye ne-refractory anaplastic astrocytoma.
  • Kumaphilisi e-Temodar, ulwazi ngezingozi zokuchayeka kumaphilisi avuliwe lwengezwa ngaphansi kokuthi Izexwayiso Nezinyathelo Zokuqaphela.
  • Ingxenye Yolwazi Lokwelulekwa Kwesiguli kanye nedokhumenti Yolwazi Lwesiguli ziyabuyekezwa futhi zibuyekezwe.

 

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Okuningi Okuzohlolwa

I-Lutetium Lu 177 dotatate igunyazwe yi-USFDA yeziguli zezingane ezineminyaka engu-12 nangaphezulu nge-GEP-NETS
Cancer

I-Lutetium Lu 177 dotatate igunyazwe yi-USFDA yeziguli zezingane ezineminyaka engu-12 nangaphezulu nge-GEP-NETS

I-Lutetium Lu 177 dotatate, ukwelashwa okuyisimangaliso, isanda kuthola imvume evela kwa-US Food and Drug Administration (FDA) yeziguli zezingane, okumaka ingqopha-mlando ku-oncology yezingane. Lokhu kugunyazwa kumelele ukukhanya kwethemba ezinganeni ezilwa nezimila ze-neuroendocrine (NETs), uhlobo lomdlavuza oluyivelakancane kodwa oluyinselele oluvame ukufakazela ukumelana nemithi evamile.

I-Nogapendekin alfa inbakicept-pmln igunyazwe yi-USFDA yomdlavuza wesinye ongasabeli we-BCG ongaphenduli.
Umdlavuza wesibeletho

I-Nogapendekin alfa inbakicept-pmln igunyazwe yi-USFDA yomdlavuza wesinye ongasabeli we-BCG ongaphenduli.

“I-Nogapendekin Alfa Inbakicept-PMLN, i-immunotherapy enoveli, ibonisa isithembiso ekwelapheni umdlavuza wesinye uma kuhlanganiswa nokwelashwa kwe-BCG. Le ndlela yokusungula iqondise izimpawu ezithile zomdlavuza ngenkathi isebenzisa impendulo yamasosha omzimba, ithuthukisa ukusebenza kahle kwemithi yokwelapha yendabuko efana ne-BCG. Izivivinyo zemitholampilo zembula imiphumela ekhuthazayo, ekhombisa imiphumela ethuthukisiwe yesiguli kanye nentuthuko engaba khona ekulawuleni umdlavuza wesinye. Ukusebenzisana phakathi kwe-Nogapendekin Alfa Inbakicept-PMLN kanye ne-BCG kumemezela inkathi entsha yokwelashwa komdlavuza wesinye.”

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