August 2021: The FDA granted amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
Iyo Guardant360® CDx (Guardant Health, Inc.) yakagamuchirwawo neDFA seshamwari yekuongorora yeamivantamab-vmjw.
CHRYSALIS, multicenter, isiri-yakasarudzika, yakavhurika chitambi, multicohort kiriniki kutongwa (NCT02609776) iyo yaisanganisira varwere vane nharaunda yepamusoro kana metastatic NSCLC vaive neEGFR exon 20 yekuisa shanduko, yakashandiswa kuwana tendero. Kubudirira kwakaongororwa muvarwere makumi masere nemasere vane NSCLC yepamusoro vane EGFR exon makumi maviri ekuisa shanduko uye vaive vafambira mberi mushure mekurapwa kweplatinamu. Amivantamab-vmjw yakapihwa kuvarwere kamwe chete pasvondo kwevhiki ina, uyezve pavhiki mbiri dzese kudzamara hosha ichiwedzera kana huturu husingagamuchiriki.
Yakazara yekupindura mwero (ORR) zvinoenderana neRECIST 1.1 sekuongororwa nemapofu akazvimirira epakati ongororo (BICR) uye nguva yekupindura ndiyo yakakosha mhedzisiro mhedzisiro matanho. Nenguva yepakati yekupindura yemwedzi gumi ne11.1, iyo ORR yaive 40% (95 muzana CI: 29 muzana, 51 muzana) (95 muzana CI: 6.9, haina kuongororwa).
Mapundu, mhinduro dzakanangana neiyo infusion, paronychia, musculoskeletal pain, dyspnea, kuda kurutsa, kupera simba, edoema, stomatitis, chikosoro, kupatira, uye kurutsa ndizvo zviitiko zveparutivi zvakanyanya (20%).
Iyo yakakurudzirwa dosi yeamivantamab-vmjw ndeye 1050 mg yevarwere vane hwaro hwepasi hwehuremu hwekusakwana 80 kg uye 1400 mg kune avo vane huremu hwemuviri hwepashure hunopfuura makumi masere makirogiramu, vanopihwa vhiki nevhiki kwevhiki ina uyezve vhiki mbiri dzese kusvika chirwere kufambira mberi kana hutachiona husingagamuchiriki kunoitika.
Dheuteronomio:
Tarisa uone pano.
