->

I-Amivantamab-vmjw ithola imvume esheshayo evela ku-FDA yomdlavuza wamaphaphu weseli ongesona omncane

Yabelana ngalokhu okuthunyelwe

Agasti 2021: I-FDA inikeze i-amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), i-bispecific antibody eqondiswe ngokumelene ne-epidermal growth factor (EGF) kanye nama-MET receptors, ukugunyazwa okusheshayo ezigulini ezikhulile ezinomdlavuza wamaphaphu osezingeni eliphezulu noma we-metastatic ongewona omncane (NSCLC) abanokuguqulwa kwe-epidermal growth factor receptor (EGFR) exon 20, njengoba kutholwe ukuhlolwa okugunyazwe yi-FDA.

I-Guardant360® CDx (i-Guardant Health, Inc.) iphinde yamukelwa yi-FDA njengocwaningo lokuhambisana lwe-amivantamab-vmjw.

I-CHRYSALIS, ilebuli evulekile eningi, engahleliwe, evulekile, isilingo somtholampilo se-multicohort (NCT02609776) ebandakanya iziguli ezine-NSCLC ezithuthukile endaweni noma ezine-metastatic ezazine-EGFR exon 20 insertion changes, yasetshenziselwa ukuthola imvume. Ukusebenza kuhlolwe ezigulini ezingama-81 ezine-NSCLC esezingeni eliphakeme ezazine-EGFR exon izinguquko ezingama-20 zokufaka futhi zathuthuka ngemuva kokwelashwa okwenziwe ngeplathinamu. I-Amivantamab-vmjw yanikezwa iziguli kanye ngesonto amasonto amane, bese kuthi njalo emavikini amabili kuze kube ukukhula kwesifo noma ubuthi obungamukeleki.

Izinga lokuphendula selilonke (i-ORR) ngokuya nge-RECIST 1.1 njengoba kuhlolwe ngokubuyekezwa okuzimele okuyimpumputhe (i-BICR) nesikhathi sokuphendula bekuyizinyathelo ezibalulekile zomphumela wokusebenza. Ngesikhathi sokuphendula esiphakathi kwezinyanga eziyi-11.1, i-ORR ibingama-40% (amaphesenti angama-95 we-CI: amaphesenti angama-29, amaphesenti angama-51) (amaphesenti angama-95 we-CI: 6.9, angahlolwa).

Ukuqubuka, izimpendulo ezihlobene nokumnika, i-paronychia, ubuhlungu be-musculoskeletal, i-dyspnea, isicanucanu, ukukhathala, i-edoema, i-stomatitis, ukukhwehlela, ukuqunjelwa, nokuhlanza kwakuyimicimbi eseceleni edume kakhulu (20%).

Umthamo onconywayo we-amivantamab-vmjw ungu-1050 mg weziguli ezinesisindo somzimba esingaphansi kwama-80 kg no-1400 mg kulabo abanesisindo sokuqala esingaphezu kuka-80 kg, esinikezwa masonto onke amasonto amane bese njalo njalo emavikini amabili kuze kube yisifo ukuqhubeka noma ubuthi obungamukeleki kwenzeka.

 

Izikhombo: 

https://www.fda.gov/

Bheka imininingwane lapha.

Thatha umbono wesibili mayelana nokwelashwa komdlavuza wamaphaphu


Thumela Imininingwane

Bhalisa ku-Newsletter yethu

Thola izibuyekezo futhi ungalokothi uphuthelwe ibhulogi evela kuCancerfax

Okuningi Okuzohlolwa

I-CAR T Cell Therapy Esekelwe Kubantu: Ukuphumelela Nezinselele
Ukwelashwa kwe-CAR T-Cell

I-CAR T Cell Therapy Esekelwe Kubantu: Ukuphumelela kanye Nezinselele

Ukwelashwa kwe-CAR T-cell okusekelwe kumuntu kuguqula ukwelashwa komdlavuza ngokushintsha izakhi zofuzo amaseli omzimba esiguli ukuze aqondise futhi abhubhise amaseli omdlavuza. Ngokusebenzisa amandla esimiso somzimba sokuzivikela ezifweni, lezi zindlela zokwelapha zinikeza ukwelashwa okunamandla futhi okuqondene nomuntu okungahle kube nokuxolelwa okuhlala isikhathi eside ezinhlotsheni ezihlukahlukene zomdlavuza.

admin Kwangathi 4, 2024
Ukuqonda I-Cytokine Release Syndrome: Izimbangela, Izimpawu, Nokwelashwa
Ukwelashwa kwe-CAR T-Cell

Ukuqonda I-Cytokine Release Syndrome: Izimbangela, Izimpawu, Nokwelashwa

I-Cytokine Release Syndrome (CRS) iwukusabela kwamasosha omzimba okuvame ukubangelwa izindlela zokwelapha ezithile ezifana ne-immunotherapy noma i-CAR-T cell therapy. Kuhilela ukukhululwa ngokweqile kwama-cytokines, okubangela izimpawu ezisukela kumkhuhlane nokukhathala kuya ezinkingeni ezingase zibeke ukuphila engozini njengokulimala kwesitho. Ukuphatha kudinga ukuqapha ngokucophelela kanye namasu okungenelela.

Alysha Mendossa April 29, 2024

Dinga usizo? Ithimba lethu likulungele ukukusiza.

Sifisela ukululama okusheshayo kothandekayo wakho futhi oseduze.

Xhumana nathi
Qala ingxoxo
Siku-inthanethi! Xoxa Nathi!
Skena ikhodi
Sawubona,

Siyakwamukela kuCancerFax!

ICancerFax iyinkundla yokuphayona ezinikele ekuxhumaniseni abantu ababhekene nomdlavuza oseqophelweni eliphezulu ngemithi yokwelapha yamangqamuzana efana ne-CAR T-Cell therapy, ukwelashwa kwe-TIL, nezivivinyo zomtholampilo emhlabeni wonke.

Sazise ukuthi yini esingakwenzela yona.

1) Ukwelashwa komdlavuza phesheya?
2) Ukwelashwa kwe-CAR T-Cell
3) Umuthi wokugomela umdlavuza
4) Ukubonisana ngevidiyo eku-inthanethi
5) Ukwelashwa kweProton