Hukumar Abinci da Magunguna ta amince da amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) a hade tare da carboplatin da pemetrexed a kan Maris 1, 2024. Marasa lafiya da epidermal girma factor receptor (EGFR) exon 20 shigar maye maye, gano ta hanyar FDA-amince. gwajin, sun cancanci wannan magani a matsayin farkon farfaganda don ci gaba na gida ko ciwon daji mara ƙananan ƙwayoyin cuta (NSCLC).
FDA ta amince da ita don amfani da shi akan manya marasa lafiya tare da ci gaba na gida ko NSCLC masu haɓakawa waɗanda ke da maye gurbin shigar da EGFR exon 20, wanda gwajin da FDA ta yarda da shi zai iya tabbatar da shi, kuma wanda yanayinsa ya yi muni bayan jiyya na tushen platinum. FDA ta riga ta ba da izini cikin sauri don wannan dalili.
Gwajin PAPILLON (NCT04538664) ya kalli yadda yake aiki sosai. Ya kasance bazuwar, buɗaɗɗen lakabin, binciken cibiyar da yawa tare da marasa lafiya 308 waɗanda ke da maye gurbi na EGFR exon 20. An sanya marasa lafiya bazuwar a cikin rabo na 1: 1 don karɓar ko dai amivantamab-vmjw tare da carboplatin da pemetrexed ko carboplatin da pemetrexed.
Ma'auni na farko na tasiri shine tsira ba tare da ci gaba ba (PFS) wanda aka kimanta ta hanyar nazari na tsakiya mai zaman kansa (BICR), tare da rayuwa gabaɗaya (OS) a matsayin muhimmiyar ƙarshen sakandare. Matsakaicin haɗari na 0.40 (95% CI: 0.30-0.53; p-darajar <0.0001) ya nuna cewa amivantamab-vmjw tare da carboplatin da pemetrexed sun inganta rayuwa marar ci gaba idan aka kwatanta da carboplatin da pemetrexed kadai. Matsakaicin ci gaba-free rayuwa (PFS) ya kasance watanni 11.4 tare da tazarar amincewa ta 95% (CI) na 9.8 zuwa 13.7 a hannu ɗaya, da watanni 6.7 tare da 95% CI na 5.6 zuwa 7.3 a ɗayan hannu.
Ko da yake ba a cika kididdigar rayuwa gabaɗaya ba a cikin bincike na yanzu, tare da kawai 44% na adadin mutuwar da aka ƙayyade don bincike na ƙarshe, babu wata alama ta wani mummunan yanayi.
Mafi rinjayen illa (≥20%) sun haɗa da kurji, ƙusa mai guba, stomatitis, amsa mai alaƙa da jiko, gajiya, edema, maƙarƙashiya, rage cin abinci, tashin zuciya, COVID-19, gudawa, da amai.
Nauyin jikin mai haƙuri yana ƙayyade adadin shawarar amivantamab-vmjw. Koma zuwa umarnin sayan magani don madaidaicin bayanan adadin.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
