Agusta 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.
FDA ta kuma amince da Guardant360® CDx (Guardant Health, Inc.) a matsayin abokin bincike na amivantamab-vmjw.
CHRYSALIS, multicenter, non-randomized, buɗaɗɗen lakabin, gwaji na asibiti na multicohort (NCT02609776) wanda ya haɗa da marasa lafiya tare da ci gaba na gida ko NSCLC mai mahimmanci wanda ke da maye gurbin shigar da EGFR exon 20, an yi amfani dashi don samun amincewa. An kimanta inganci a cikin marasa lafiya 81 tare da ci-gaba NSCLC waɗanda ke da maye gurbi na EGFR exon 20 kuma sun ci gaba bayan jiyya na tushen platinum. Ana ba da Amivantamab-vmjw ga marasa lafiya sau ɗaya a mako har tsawon makonni huɗu, sannan kowane mako biyu har sai cutar ta ci gaba ko kuma gubar da ba za a yarda da ita ba.
Yawan amsa gabaɗaya (ORR) bisa ga RECIST 1.1 kamar yadda aka tantance ta hanyar nazari na tsakiya mai zaman kansa (BICR) da tsawon lokacin amsawa sune mahimman matakan sakamako na inganci. Tare da lokacin amsawa na tsaka-tsaki na watanni 11.1, ORR ya kasance 40% (95 bisa dari CI: 29 bisa dari, 51 bisa dari) (95 bisa dari CI: 6.9, ba mai daraja ba).
Rash, martani masu alaƙa da jiko, paronychia, ciwon musculoskeletal, dyspnea, tashin zuciya, gajiya, edoema, stomatitis, tari, maƙarƙashiya, da amai sune abubuwan da ke faruwa a gefe (20%).
Adadin da aka ba da shawarar amivantamab-vmjw shine 1050 MG ga marasa lafiya tare da nauyin nauyin jiki na asali na kasa da 80 kg da 1400 MG ga waɗanda ke da nauyin nauyin jiki fiye da 80, ana ba da mako-mako har tsawon makonni hudu sannan kowane mako biyu har sai cututtuka. ci gaba ko rashin yarda da guba yana faruwa.
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Duba cikakkun bayanai nan.
