I-Gazyva (i-Obinutuzumab) iyeza elifana neRituxan (rituximab) kwaye iphandwa kwiindidi ezahlukeneyo zeengqimba zegazi, kubandakanywa izifundo ezininzi zekliniki kwi-non-Hodgkin's lymphoma (NHL). NjengoRituxan, i-Gazyva isetyenziselwa ukudibanisa ne-chemotherapy ukuze unyango lwegazi lamanye. Inqaku likaGenentech kunye neRoche inqaku lokuba kukho izifundo ezininzi eziqhubekayo ngokuthelekisa i-obinutuzumab kunye ne-rituximab kwi-lymphoma engekho-Hodgkin ye-indolent kunye ne-B-cell lymphoma enkulu.
I-Gazyva ngoku ivunyiwe yi-FDA ukusetyenziswa kwezinye izigulane nge-lymphoma ye-follicular, ngaphezu kokusetyenziselwa ukusetyenziswa kwe-leyemia ye-lymphocytic, okanye i-CLL engapheliyo. Kwi-CLL, i-Gazyva idibene ne-chlorambucil; i-follicular lymphoma, i-Gazyva idibene ne-bendamustine.
Malunga ne-Follicular Lymphoma
Nangona engekho i- lymphoma eqhelekileyo, i-lymphoma ye-follicular ibeka phakathi kwezinto eziqhelekileyo ezifunyaniswe i-lymphoma. Iindidi ezibini ze-lymphoma zi- Hodgkin kunye ne-non-Hodgkin's lymphoma. I-lymphoma yenkoliso yinto engeyiyo ye-Hodgkin kwaye iyona eqhelekileyo kwi-indolent, okanye i-lymphomas (non-Hodgkin's lymphomas).
Nangona ikhula ngokukhawuleza, ihlala ingumdlavuza ongenakuphulukiswa oba nzima kakhulu ukunyanga rhoqo xa ubuya. Iingxelo ze-lymphoma zeenkcukacha ezimalunga nesinye sezihlandlo ezi-5 ze-NHL e-United States, apho bekuqikelelwa ukuba iziganeko ezingaphezulu kwe-14 000 ezitsha ziya kufumaneka ngo-2015.
Njengoko izigulane ezininzi zigcina ngempumelelo ukubola, ukufumana unyango olutsha luyakwamkela.
Gazyva yeLymphoma yeFollic
"Abantu abane-lymphoma ye-follicular abanesi sifo okanye ababuhlungu nangona unyango lwe-Rituxan ene-regimen idinga ukhetho olungakumbi ngenxa yokuba isifo sinobunzima ukunyanga rhoqo xa sibuya," kusho uSandra Horning, MD, igosa lezempilo kunye nentloko ye-Global Product. Phuhliso.
"I-Gazyva kunye ne-bendamustine inikeza inketho entsha yonyango engasetyenziselwa emva kokuphindaphinda ekunciphiseni kakhulu umngcipheko wokuqhubela phambili okanye ukufa."
Imvume ye-FDA yeGazyva yayisekelwe kwiziphumo ezivela kwiSigaba se-III se-GADOLIN, esabonisa ukuba, kubantu abane-lymphoma ye-follicular esinezifo eziqhubekileyo ngexesha okanye ezintandathu ezintandathu ngaphambi kokuba unyango lwe-Rituxan, i- Gazyva kunye ne-bendamustine elandelwa nguGazyva yodwa ibonise i-52 ukunciphisa ipesenti kwengozi yezifo eziqhubekayo okanye ukufa (ukusinda okungaqhubekiyo, i-PFS), xa kuthelekiswa ne-bendamustine yedwa.
Indlela Gazyva isebenza ngayo
I-Gazyva, njengeRituxan, i-antioclonal antibody. Okokuthi, luhlobo olukhethekileyo lwe-antibody olwenziwa yizenzululwazi kwaye luveliswe ngabavelisi. Imveliso yokugqibela ixhomekeke kwisikhwama njengelwelo kwaye inikwe ngokunyuswa kwe-intravenous.
NjengoRituxan, uGazyva ijolise i-CD20 antigen. I-anti-CD20-antigen ifana ne-tag ebonakalayo-yinto ebonakalayo ebonakalayo phezu kwamaseli athile, kuquka neeseli ezimhlophe zegazi ezibizwa ngokuba yi-B-lymphocytes, okanye iiseli ze-B. Iiseli ze-B ezingapheliyo, ezibizwa ngokuba ngama-cell-pre-B , nazo zine-CD20 antigen.
Xa i-obinutuzumab ibophelela kwi-CD20, oku kuholele ekufeni kwaye kuchithe ukuvuleka kwama cell B. Ukwenza oko ngokuthatha amanye amaseli omzimba ukuba enze umsebenzi, ngokusebenzisa ngokuthe ngqo iimpawu zokufa kunye / okanye ukwenza into ebizwa ngokuba yinkxaso yokuphelisa-i-series of chemical reaction of your system's immune system, ukubonisa imfuneko yokufuna nokuyichitha.
I-Gazyva ihluke njani kwiRituxan? Ekubeni, ngokubhekiselele kubenzi beziyobisi, uGazyva ucingelwa ukuba unamandla okwandisa ukufa kwesisele ngokuthe ngqo-into ebizwa ngokuba yi-anti-man-dependent celtlar cytotoxicity (ADCC) - kwaye ibangela ukuba umsebenzi omkhulu usebenze ngendlela yokubuyisela umzimba womzimba ukuhlasela B-iiseli xa kuthelekiswa ne-rituximab. Enyanisweni, kwizifundo zengqungquthela, i-Gazyva inikelwe ukunyuka kwama-35 kwi-ADCC xa kuthelekiswa neRituxan. I-Gazyva nayo yavusa izibonakaliso zokufa ngaphakathi kwiiseli ze-B kwizifundo ezicwangcisiweyo.
Imiphumela
Ukhuseleko lweGazyva lwavavanywa ngokusekelwe kwizigulane ezingama-392 ezineNhlanhla ye-indol, enama-81 ekhulwini ayenayo i-follicular lymphoma.
Kwizigulane ezine-lymphoma ye-follicular, iimpembelelo eziqhelekileyo eziye zabonwa zihambelana noluntu jikelele oluneNHL.
Iziphumo eziqhelekileyo ezichaphazelekayo zeGazyva ziyi-reaction, ukunyuka, ukukhwehlela, isifo sohudo, ukugqithisa, umkhuhlane, ukubalwa kweplatelet, ukuhlanza, ukutheleleka kwendlela yokuphefumula, ukunciphisa intlanzi, intlungu edibeneyo okanye i-muscle, i-sinusitis, Ubunzima besibalo segazi obomvu, ubuthakathaka ngokubanzi, kunye nokusuleleka kwe-urinary tract tract.
Kuqhelekileyo kodwa iziphumo zecala lokusongela ubomi zichazwe oogqirha abayalela ulwazi, ngamanye amaxesha bathabatha uhlobo "lwesilumkiso esibhokisayo." Kwi-Gazyva, isilumkiso esinobhokisi siquka ulwazi malunga neentsholongwane ezimbini zentsholongwane: I-Hepatitis B Virus (HBV) ukuvuselelwa kwamanye amaxesha kubangela ukulimala kwesibindi nokufa; kunye nentsholongwane ye-JC intsholongwane ye-Multifocal Leukoencephalopathy (PML) eyenza ukufa.
Ukuze ukhuseleko olupheleleyo kunye neprofayili yokuphumelela yeGazyva kwi-lymphoma yesalulo, nceda ubone ulwazi lwe-Gazyva Prescribing Information.
Imithombo:
1. Gazyva Ukuchazela ulwazi.
2. Mössner E, Brünker P, Moser S, et al. Ukwandisa ukuphumelela kwe-CD20 yonyango lolwaphulo-mthetho ngokusebenzisa ubunjineli wolu hlobo olutsha lwe-anti-CD20 olunefuthe elichanekileyo kunye ne-immune effecter cell-mediated B-cell cytotoxicity. Igazi . 2010; 115 (22): 4393-4402.
3. Herter S, Herting F, Mundigl O, et al. Umsebenzi wokucwangcisa uhlobo lwe-II CD-antibody GA101 (obinutuzumab) ngokuthelekiswa ne-rituximab kunye ne -atumumab in vitro kunye nemizekelo ye-xenograft. I-Mol Cancer Ther . 2013; 12 (10): 2031-2042.
4. Klein C, uLammens A, Schäfer W, et al. Intsebenziswano ye-epitope yamanqindi omzimba alawulwa yiCD20 kunye nolwalamano lwabo kunye nepropati ezisebenzayo. mAbs . 2013; 5 (1): 22-33.