I-Gazyva (i-Obinutuzumab) imithi efana ne-Rituxan (rituximab) futhi iyaphenywa kuzo zonke izinhlobo zegazi zamangqamuzana egazi, kuhlanganise nezifundo eziningi zemitholampilo ku-non-Hodgkin's lymphoma (NHL). NjengesiRituxan, i-Gazyva isetshenziselwa ukuhlanganiswa ne-chemotherapy ukuze ukwelashwa kwamanye amagciwane egazi. Abadakamizwa uGenentech noRoche inothi ukuthi kunezifundo eziningi eziqhubekayo eziqhathaniswa ne- obinutuzumab ne-rituximab e-indolent non-Hodgkin's lymphoma kanye ne-B-cell lymphoma enkulu.
I-Gazyva manje ivunyelwe i-FDA ukuze isetshenziswe kwezinye iziguli ezine-lymphoma ye-follicular, ngaphezu kwalokho kusetshenziswe ukusetshenziswa ku-lemonic lymphocytic, noma i-CLL. Ku-CLL, iGazyva ihlangene ne-chlorambucil; for follicular lymphoma, i-Gazyva ihlangene ne-bendamustine.
Mayelana ne-Follicular Lymphoma
Nakuba kungenjalo i - lymphoma ejwayelekile kakhulu, i-follicular lymphoma ibeka phakathi kwezinhlobo ezivame ukutholakala nge-lymphoma. Izigaba ezimbili eziyisisekelo ze-lymphoma yi- Hodgkin's non-Hodgkin's lymphoma. I-follicular lymphoma iyinhlobo engeyona i-Hodgkin futhi iyona evame kakhulu kwi-lymphomas e-indolent, noma ekhula kancane, engeyona i-Hodgkin's (NHL).
Nakuba ikhula kancane, ihlala ingumdlavuza ongelapheki oba nzima kakhulu ukwelapha isikhathi ngasinye lapho siphindela emuva. I-Follicular lymphoma ilandisa ngamacala amahlanu we-NHL e-United States, lapho kulinganiselwa ukuthi amacala amasha angaphezu kuka-14 000 ayotholakala ngo-2015.
Njengoba iziguli ezengeziwe zigcina ngempumelelo ukulimala, izifo ezintsha zamukelekile ngokukhethekile.
I-Gazyva ye-Follicular Lymphoma
"Abantu abane-follicular lymphoma abanesifo esibuhlungu noma abagulayo naphezu kokwelashwa ne-Rituxan-containing containing regimen badinga izinketho eziningi ngoba lesi sifo sibe nzima kakhulu ukuphatha ngaso sonke isikhathi lapho siphindela emuva," kusho uSandra Horning, MD, isikhulu sezokwelapha kanye nomholi we-Global Product Ukuthuthukiswa.
"I-Gazyva kanye ne-bendamustine inikeza ukhetho olusha olungasetshenziswa ngemuva kokubuyela emuva ukuze kunciphise kakhulu ingozi yokuqhubeka noma yokufa."
Ukugunyazwa kwe-FDA kaGazyva kwakusekelwe emiphumeleni yocwaningo lwesigaba se-III GADOLIN, okubonisa ukuthi, kubantu abane-follicular lymphoma abanesifo esiqhubekayo phakathi nezinyanga eziyisithupha ngaphambi kwe-Rituxan-based therapy, uGazyva plus bendamustine elandelwa uGazyva yedwa yabonisa u-52 ukuncipha kwamaphesenti engozini yezifo ezimbi kakhulu noma ukufa (ukuqhubeka okuqhubekayo okuqhubekayo, PFS), kuqhathaniswa ne-bendamustine yedwa.
Indlela Gazyva Isebenza ngayo
I-Gazyva, njenge-Rituxan, i-antibody monoclonal. Okusho ukuthi, uhlobo olukhethekile lwe-antibody olwenziwa ngabaososayensi futhi olwenziwe abakhiqizi. Umkhiqizo wokugcina uphonswa esikhwameni njengoketshezi futhi unikezwe ngokumnika okufakwe ngaphakathi.
NjengoRituxan, iGazyva ihlose i-CD20 antigen. I-CD20 antigen ifana nomaka okhomba - iyinkimbinkimbi yamaprotheni ekhona emangqamuzaneni athile, kuhlanganise namaseli amhlophe egazi aziwa ngokuthi ama-B-lymphocytes, noma amaseli B. Amaseli ase-Immature B, okuthiwa amangqamuzana angaphambi kwe-B , nawo anawo le-anti-CD20.
Uma i-obinutuzumab ibophezela ku-CD20, lokhu kuholela ekufeni futhi kuchithe ukuvuleka kwama cell B. Lokhu kwenza ngokuqasha amanye amangqamuzana omzimba ukuze wenze lo msebenzi, ngokusebenzisa ngokuqondile izibonakaliso zokufa kanye / noma ukwenza into ebizwa ngokuthi i-complement cascade - uchungechunge lwempikiswano yamakhemikhali omzimba wakho osetshenziswayo, okubonisa isidingo sokufuna nokubhubhisa.
I-Gazyva ihluke kanjani ku-Rituxan? Ngokusho kwabenzi bezidakamizwa, uGazyva kucatshangwa ukuthi unamandla okwandisa ukubulala ukufa kwe-cell cell - into ebizwa ngokuthi i-cytotoxicity (ADCC) ebizwa ngokuthi i-antibody-dependent cell (i-ADCC) - futhi yenza umsebenzi omkhulu ekusebenziseni amasosha omzimba ukuze ahlasele B-amaseli uma kuqhathaniswa ne-rituximab. Eqinisweni, ekuhlolisweni kwe-preclinical, i-Gazyva yanikezela ngokunyuka kwama-35 ku-ADCC kuqhathaniswa ne-Rituxan. I-Gazyva iphinde isetshenziselwe izimpawu zokufa ngaphakathi kwamaseli e-B ezifundweni zangasese.
Okuqhamuka uma udla imishanguzo
Ukuphepha kweGazyva kwahlolwe ngokusekelwe ezigulini ezingu-392 ezinezintatheli ze-NHL, ezingamaphesenti angu-81 ayenayo i-follicular lymphoma.
Ezigulini ezine-follicular lymphoma, imiphumela emibi kakhulu ebonakalayo yayivumelana nabantu bonke ababenama-NHL abadabukisayo.
Imiphumela emibi kakhulu ye-Gazyva yizimpendulo zokungenisa ukumfutho, ukuhlukunyezwa kwamangqamuzana egazi omhlophe, ukukhwabanisa, ukukhathala, ukukhwehlela, isifo sohudo, ukuqothulwa, umkhuhlane, ukubala okuphansi, ukuhlanza, ukutheleleka okuphezulu kokuphefumula, ukwehlisa isifiso, ubuhlungu obuhlangene noma ubuhlungu, isisusitis, ukubala okuncane okubomvu kwegazi, ukubuthakathaka jikelele, nokutheleleka kwamagciwane.
Ngokuvamile kodwa imiphumela emibi yokusongela impilo iyabika ngolwazi odokotela 'olwenzela ulwazi, ngezinye izikhathi lithatha uhlobo' lokuxwayisa okwesibhokisi. ' Ku-Gazyva, lesi sixwayiso esinesihluthulelo sihlanganisa ulwazi mayelana nokutheleleka okubili kwegciwane: Ukuvuselelwa kwe-Hepatitis B Virus (HBV) kwezinye izimo kubangela ukulimala kwesibindi nokufa; futhi i-JC virus ukutheleleka i-Progressive Multifocal Leukoencephalopathy (PML) eholela ekufeni.
Ukuze uthole ukuphepha okuphelele kanye nephrofayili ephumelelayo ye-Gazyva ku-follicular lymphoma, sicela ubheke ulwazi lwe-Gazyva Prescribing.
Imithombo:
1. Gazyva Ukuchaza Ulwazi.
2. Mössner E, Brünker P, Moser S, et al. Ukwandisa ukusebenza kwe-CD20 anti -body's therapy ngokusebenzisa ubunjiniyela obunamachiza omuthi omusha we-type II anti anti-CD20 onomsoco onamandla omzimba kanye nomzimba wokuzivikela omzimba we-B-cell cytotoxicity. Igazi . 2010; 115 (22): 4393-4402.
3. Herter S, Herting F, Mundigl O, et al. Umsebenzi wokucubungula ohlobo lwe-II CD anti-CD20 GA101 (obinutuzumab) uma kuqhathaniswa ne-rituximab ne -atumumab in vitro kanye nama-xenograft model. I-Cancer ye-Mol 2013; 12 (10): 2031-2042.
4. Klein C, Lammens A, Schäfer W, et al. Ukusebenzisana kwe-Epitope yama-antibodies e-monoclonal ahlose i-CD20 nobuhlobo bawo nezakhiwo zokusebenza. AmAbs . 2013; 5 (1): 22-33.