I-Pembrolizumab ene-chemotherapy igunyazwe yi-USFDA yomdlavuza we-biliary tract

I-Pembrolizumab ene-chemotherapy igunyazwe yi-USFDA yomdlavuza we-biliary tract

Yabelana ngalokhu okuthunyelwe

Ngomhla zingama-31 ku-Okthoba 2023, Ukuphathwa Kwezokudla Nezidakamizwa kugunyaze i-pembrolizumab (Keytruda, Merck) ukuthi isetshenziswe ne-gemcitabine ne-cisplatin ukwelapha i-biliary tract carcinoma (BTC) esabalale noma ethuthuke kakhulu endaweni kodwa engakwazi ukususwa.

Ukusebenza kahle kwahlolwa ocwaningweni olubizwa nge-KEYNOTE-966 (NCT04003636), okwakuyisivivinyo esilawulwa yi-multicenter, randomized, double-blind, ne-placebo esihilela iziguli ezingu-1069 ezine-BTC ethuthukisiwe engatholakali noma ye-metastatic engazange ithole ukwelashwa okuhlelekile kwangaphambilini kokugula okuthuthukile. . Iziguli zabelwa ngokungahleliwe ukuthi zithole noma i-pembrolizumab ihlanganiswe ne-gemcitabine ne-cisplatin njalo emavikini angu-3, ​​noma i-placebo ihlanganiswe ne-gemcitabine ne-cisplatin ohlelweni olufanayo. Ukwelashwa kwaqhubeka kwaze kwaba nemiphumela emibi engabekezeleleki noma ukukhula kwesifo. I-Cisplatin inikezwe imijikelezo efinyelela kweyisi-8, kanti i-gemcitabine yaqhutshekwa ngokususelwa kusinqumo sikadokotela. Ukuphathwa kwe-Pembrolizumab noma i-placebo kwagcinwa kuze kube yilapho ukugula kuqhubeka, ubuthi obungabekezeleleki, noma isikhathi esiphezulu seminyaka emi-2.

Isiphetho esiyinhloko sokusebenza kwaba ukusinda okuphelele (OS). I-Pembrolizumab ehlanganiswe nokwelashwa ngamakhemikhali ibonise ukwanda okukhulu kokusinda kukonke uma kuqhathaniswa ne-placebo ehlanganiswe ne-chemotherapy, enesilinganiso sengozi esingu-0.83 (95% CI: 0.72, 0.95); inombolo ye-p yohlangothi olulodwa=0.0034. Ukusinda okuphelele okumaphakathi (OS) kwakuyizinyanga ezingu-12.7 ngesikhawu sokuzethemba esingu-95% (CI) sika-11.5 kuya ku-13.6 eqenjini elilodwa, kanye nezinyanga ezingu-10.9 no-95% CI ka-9.9 kuya ku-11.6 kwelinye iqembu.

Ukuphazamiseka kwe-pembrolizumab ngenxa yezehlakalo ezimbi kwenzeke ku-55% weziguli. Isibalo esiphansi se-neutrophil, isibalo esiphansi seplatelet, i-anemia, isibalo esiphansi samangqamuzana amhlophe egazi, imfiva, ukukhathala, i-cholangitis, i-ALT ephakeme ne-AST, kanye nokuvinjwa kwe-biliary kwakungeminye yemiphumela emibi noma izinkinga zelebhu ezenzeka kaningi (≥2%) kangangokuthi ukwelashwa kwadingeka kumiswe.

Umthamo ophakanyisiwe we-pembrolizumab ngu-200 mg njalo emavikini angu-3 noma u-400 mg njalo emavikini angu-6 kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki. Sebenzisa i-pembrolizumab ngaphambi kokwelashwa ngamakhemikhali uma zombili zinikezwa ngosuku olufanayo.

Buka imininingwane egcwele ye-Keytruda.

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