November 2022: Kune varwere vakuru vanga vaine imwe kusvika kumatatu ekutanga systemic kurapwa regimens uye vane folate receptor alpha (FR) yakanaka, platinamu-resistant epithelial ovarian, fallopian chubhu, kana yekutanga peritoneal cancer, iyo Food and Drug Administration yakapa kukurumidza kubvumidzwa kune mirvetuximab soravtansine- gynx (Elahere, ImmunoGen, Inc.). A microtubule inhibitor uye folate receptor alpha inotungamirwa antibody inosanganiswa mumirvetuximab soravtansine-gynx. Muedzo wakatenderwa neFDA unoshandiswa kuona kuti ndevapi varwere vachawana kurapwa.
Iyo VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) ichangobva kupihwa mvumo yeFDA sechishandiso chekuongorora mashandiro echiratidzo chambotaurwa.
Kudzidza 0417 (NCT04296890), kuedza kweruoko rumwe chete kunosanganisira varwere ve106 vane FR-positive, platinum-resistant epithelial ovarian, fallopian tube, kana kenza yekutanga yeperitoneal, yakaongorora kushanda kwekurapa. Kusvikira kumitsara mitatu yapfuura ye systemic therapy yakabvumirwa kune varwere. Bevacizumab yaive kudiwa kwevarwere vese. Varwere vane mapundu akaedzwa kuti akanaka kune FR kutaura vachishandisa assay yambotaurwa yakaverengerwa muchidzidzo. Varwere vakanga vasina kukodzera kana vaine chirwere chisingaiti chechirwere chemapapu, Giredhi> 1 peripheral neuropathy, zvinetso zvekorneal, kana zvirwere zvemaziso zvaida kuramba uchitarisirwa.
Varwere vakagamuchira intravenous infusion ye mirvetuximab soravtansine-gynx 6 mg/kg (zvichienderana neyakagadziridzwa uremu hwemuviri) mavhiki matatu ega ega kusvikira mamiriro avo aenderera mberi kana mhedzisiro yave isingashiviriki. Masvondo matanhatu ega ega mumavhiki makumi matatu nematanhatu ekutanga, uyezve masvondo gumi nemaviri mushure meizvozvo, kuongororwa kwebundu remhinduro kwakaitwa.
Kuwanda kwekupindura (ORR) uye nguva yekupindura (DOR) sekutsanangurwa nemuongorori uye kuyerwa maererano neRECIST version 1.1 ndiyo yaiva yekutanga kushanda kwemigumisiro. Iyo yakasimbiswa ORR yaive 31.7% (95% CI: 22.9, 41.6) uye yepakati DOR yaive mwedzi 6.9 (95% CI: 5.6, 9.7) mune efficacy inoongororwa sampuli yevarwere vaive neplatinamu isingadzivirirwe, quantifiable chirwere uye vakagamuchira kamwe chete. dose (104 varwere).
Kutadza kuona, kuneta, kuwedzera aspartate aminotransferase, kuda kusvotwa, kuwedzera alanine aminotransferase, keratopathy, kurwadziwa mudumbu, kuderera kwelymphocytes, peripheral neuropathy, manyoka, kuderera kwealbumin, kuvimbiswa, kuwedzera alkaline phosphatase, ziso rakaoma, kuderera kwemagnesium, kuderera kweleukocyte, kuderera kweleukocytes. kuderera kwe hemoglobin ndiyo yainyanya kuitika (20%) yakashata, kusanganisira yerabhoritari abnormalities. Pane yambiro yebhokisi yehupfu hweziso pane iyo chigadzirwa label.
Chiyero chinofungidzirwa che mirvetuximab soravtansine-gynx i6 mg/kg yakagadziridzwa uremu hwemuviri hwakanaka (AIBW), inopihwa mutsinga kamwe chete pamazuva makumi maviri nerimwe (kutenderera) kusvika pakukura kwechirwere kana huturu husingagoneki.
Wona ruzivo rwakazara rwekurayira Elahere.
