I-Food and Drug Administration igunyaze i-amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) ngokuhlanganiswa ne-carboplatin futhi yafakwa i-pemetrexed ngomhla ka-Mashi 1, 2024. Iziguli ezine-epidermal growth factor receptor (EGFR) exon 20 insertion mutations, ezikhonjwe i-FDA-approved. ukuhlolwa, bayakufanelekela lokhu kwelashwa njengokwelashwa kokuqala komdlavuza wamaphaphu wamaphaphu othuthukisiwe endaweni noma we-metastatic non-small cell (NSCLC).
Kugunyazwe i-FDA ukuthi kusetshenziswe ezigulini ezikhulile ezine-NSCLC ethuthukisiwe endaweni noma ene-metastatic eyayinezinguquko zokufakwa kwe-EGFR exon 20, ezingaqinisekiswa ukuhlolwa okugunyazwe i-FDA, futhi isimo sazo saba sibi kakhulu ngemva kokwelashwa okusekelwe ku-platinum. I-FDA isivele inikeze ukugunyazwa okusheshayo ngale njongo.
Isivivinyo se-PAPILLON (NCT04538664) sibheke ukuthi sisebenze kahle kangakanani. Kwakuwucwaningo olungahleliwe, oluvulekile, olunezikhungo eziningi neziguli ezingama-308 ezazinezinguquko zokufakwa kwe-EGFR exon 20. Iziguli zabelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze zithole i-amivantamab-vmjw ene-carboplatin ne-pemetrexed noma i-carboplatin ne-pemetrexed.
Isilinganiso esiyinhloko sokusebenza kwaba yi-progression-free survival (PFS) ehlolwe i- blinded independent central review (BICR), enokusinda sekukonke (OS) njengendawo yokugcina ebalulekile yesibili. Isilinganiso sengozi esingu-0.40 (95% CI: 0.30–0.53; p-value<0.0001) sibonise ukuthi i-amivantamab-vmjw kanye ne-carboplatin ne-pemetrexed kuthuthukise kakhulu ukusinda okungenanqubekela phambili uma kuqhathaniswa ne-carboplatin ne-pemetrexed iyodwa. Ukusinda kwe-median progression-free survival (PFS) kwakuyizinyanga ezingu-11.4 nge-95% isikhawu sokuzethemba (CI) se-9.8 kuya ku-13.7 engalweni eyodwa, nezinyanga ezingu-6.7 nge-95% CI ye-5.6 kuya ku-7.3 kwenye ingalo.
Nakuba zizonke izibalo zokusinda azizange zithuthukiswe ngokugcwele ekuhlaziyweni kwamanje, ngama-44% nje kuphela abantu abashonile abashiwo ngaphambili ababikwe ukuze kuhlaziywe okokugcina, kwakungekho nkomba yokuthambekela okungekuhle.
Imiphumela engemihle evelele (≥20%) ihlanganisa ukuqubuka, ubuthi bezinzipho, i-stomatitis, impendulo ehlobene nokufakwa, ukukhathala, ukuqunjelwa, ukuqunjelwa, ukuncipha kwesifiso sokudla, isicanucanu, i-COVID-19, isifo sohudo, nokuhlanza.
Isisindo somzimba wesiguli sinquma umthamo onconywayo we-amivantamab-vmjw. Bheka imiyalelo kadokotela ukuze uthole imininingwane eqondile yomthamo.
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.
Alysha Mendossa
Kwangathi 11, 2024
