Bishii Nofeembar 28, FDA waxay ansixisay rituximab-kii ugu horreeyay (Rituxan, rituximab) biosimilar, Truxima (rituximab-abbs, Celltrion Inc.) oo loogu talagalay non-Hodgkin's lymphoma (NHL).
Rituximab waa antibody monoclonal lid ku ah CD20. Waxaa si weyn loogu isticmaalaa lymphoma non-Hodgkin waxaana lagu dari karaa daaweynta kemotherabi ama kaligiis.
Daawada asalka ah waxay ahayd Roche's Rituxan (rituximab), oo markii ugu horeysay laga ansixiyay Mareykanka 1997. Waxaa jira tilmaamo kale oo ku saabsan badeecadan, oo ay ku jiraan daaweynta xanuunka loo yaqaan 'rheumatoid arthritis'.
Biosimilar-kan cusub waa Truxima (Rituximab-abbs) oo laga keenay Celltrion. Gaar ahaan, waxay khuseysaa bukaanada waaweyn:
1) Soo noqosho ama diidmo, darajo hoose ama follicle, CD20 positive B cell NHL as monotherapy
2) Xilliga hore ee aan la daaweyn, CD20 wanaagsan, B-cell NHL oo ay weheliso kiimiko-daaweynta koowaad, iyo bukaanada ku guuleystey jawaab dhammaystiran ama qayb ah oo ku saabsan rituximab oo lagu daro kiimoterapi, oo ah daaweyn hal-wakiil ah
3) Sida safka hore ee loo yaqaan 'cyclophosphamide', vincristine iyo prednisone (CVP) kiimoterapi, aan horumar ahayn (oo ay kujiraan cudur deggan), darajo hoose, CD20 togan, B cell NHL oo ah hal dawo
Taxadarrada loogu talagalay biosimilar-kan waxay la mid yihiin dawada asalka ah, oo ay ku jiraan halista falcelinta faleebo, maqaarka daran iyo falcelinta afka (qaar leh cawaaqib dhimasho); Fayraska cagaarshow B dib-u-soo-celinta iyo leukoencephalopathy multifocal oo sii socda FDA waxay xustay in waxyeellooyinka ugu badan ay yihiin falcelinta faleebo, qandho, lymphopenia, qarqaryo, caabuq, iyo daciifnimo. Waxaa lagu talinayaa in bixiyeyaasha daryeelka caafimaadku ay la socdaan bukaanka burooyinka lysis syndrome, falcelinta wadnaha ee xun, nephrotoxicity, xannibaadda mindhicirka, iyo daloolinta. Bukaanka waa in aan la tallaalin inta lagu jiro daawaynta.
