Musi waNovember 28, FDA yakabvumidza yekutanga rituximab (Rituxan, rituximab) biosimilar, Truxima (rituximab-abbs, Celltrion Inc.) kune isiri-Hodgkin's lymphoma (NHL).
Rituximab inonzi monoclonal antibody inopesana neCD20. Inoshandiswa zvakanyanya mune isiri-Hodgkin's lymphoma uye inogona kushandiswa pamwe chete nechemotherapy kana yega.
Mushonga wekutanga waive Roche's Rituxan (rituximab), iyo yakatanga kubvumidzwa muUnited States muna 1997. Pane zvimwe zvinoratidza chigadzirwa ichi, kusanganisira kurapwa kwerheumatoid arthritis.
Iyo nyowani biosimilar ndeye Truxima (Rituximab-abbs) kubva kuCelltrion. Kunyanya, zvinoshanda kuvakuru varwere:
1) Sekudzokazve kana kuramba, giredhi repasi kana follicle, CD20 yakanaka B cell NHL se monotherapy
2) Sekare isina kutorwa follicle, CD20 yakanaka, B-cell NHL inosanganiswa neyekutanga-chemotherapy chemotherapy, uye varwere vakawana zvakakwana kana kukwana mhinduro kune rituximab inosanganisirwa nekemotherapy, seyechete-mumiririri wekuchengetedza kurapwa
3) Seyekutanga-mutsara cyclophosphamide, vincristine uye prednisone (CVP) chemotherapy, isiri-inofambira mberi (inosanganisira chirwere chakatsiga), yakadzika giredhi, CD20 yakanaka, B cell NHL semushonga mumwe
Kuchenjerera kweiyi biosimilar kwakafanana nemushonga wepakutanga, kusanganisira njodzi yekuiswa mukati, yakaoma ganda uye nemuromo maitiro (zvimwe zvine mhedzisiro inouraya); Hepatitis B virus reactivation and progressive multifocal leukoencephalopathy Iyo FDA yakacherechedza kuti zvinonyanya kukonzeresa mhedzisiro infusion reactions, fever, lymphopenia, kupindwa nechando, kutapukirwa, uye kupera simba. Zvinokurudzirwa kuti vatapi vehutano vatarise varwere vane tumor lysis syndrome, maitiro akashata emwoyo, nephrotoxicity, kuvharika kwematumbo, uye kupera. Varwere havafanirwe kubaiwa majekiseni panguva yekurapa.
