Gazyva (Obinutuzumab) mushonga unofanana neRituxan (rituximab) uye uri kuongororwa pamhando dzakasiyana-siyana dzekenza yeropa, kusanganisira dzakawanda kliniki zvidzidzo mune zvisiri Hodgkin's lymphoma (NHL). Kufanana neRituxan, Gazyva inoshandiswa pamwe chete nekemotherapy yekurapa mamwe mararamiro eropa. Vagadziri vezvinodhaka Genentech naRoche vanocherechedza kuti pane dzakawanda zvidzidzo zvinoenderera mberi zvichifananidza obinutuzumab ne rituximab mu indolent isiri Hodgkin's lymphoma uye inopararira zvikuru B-cell lymphoma.
Gazyva ikozvino FDA-inogamuchirwa kuti ishandiswe mune vamwe varwere vane follicular lymphoma, kunze kweyo yakashandiswa kushandiswa mune chronic lymphocytic leukemia, kana CLL. NeCLL, Gazyva inobatanidzwa neklorambucil; for follicular lymphoma, Gazyva inobatanidzwa ne bendamustine.
Nezve Follicular Lymphoma
Kunyange zvazvo isiri iyo inowanzojairika yerymma, follicular lymphoma inowanikwa pakati pezvinowanzozivikanwa kuti lymphoma marudzi. Izvo zvikamu zviviri zvinokosha zve lymphoma ndiHodgkin uye kwete Hodgkin's lymphoma. Follicular lymphoma iyo isiri yeHodgkin uye ndiyo inowanzoshambadza ine indolent, kana kuti inononoka-kukura, isina Hodgkin's lymphomas (NHL).
Kunyange zvazvo ichikura zvishoma nezvishoma, inoramba iine kenza isingagoni kupora iyo inowedzera kuoma kurapa nguva imwe neimwe inodzoka. Follicular lymphoma inosvika kune imwe muzviitiko zvishanu zveNHL muUnited States, kwaifungidzirwa kuti inopfuura 14 000 mitsva itsva yaizoonekwa muna 2015.
Sezvo varwere vakawanda vachibudirira kuchengetedza urombo huripo, mushonga mutsva unogamuchirwa zvikuru.
Gazyva ye Follicular Lymphoma
"Vanhu vane follicular lymphoma vane chirwere chinodzoka kana kuti chinotyisa pasinei nekurapwa neRituxan-regimen regimen vanoda zvimwe zvingasarudzwa nokuti chirwere chinova chakaoma kurapa nguva imwe neimwe inodzoka," akadaro Sandra Horning, MD, chiremba mukuru uye mukuru we Global Product Development.
"Gazyva pamwe neBendamustine inopa mushonga mushonga unogona kushandiswa mushure mokudzokerazve kunobatsira zvikuru kuderedza ngozi yekufambira mberi kana kufa."
Chirongwa cheDAA cheGazyva chaibva pamigumisiro inobva kuGlasi III GADOLIN, iyo yakaratidza kuti, kune vanhu vane follicular lymphoma avo vane chirwere chakafambira mukati kana mukati pemwedzi mitanhatu yeRituxan-based therapy, Gazyva pamwe bendamustine yakatevera neGazyva chete yakaratidza 52 kupera kwemazana muhutachiwana hwehutano huri kuwedzera kana kufa (kufambira mberi-kusina kusununguka, PFS), zvichienzaniswa ne bendamustine chete.
Kuita sei Gazyva
Gazyva, seRituxan, inonzi monoclonal antibody. Izvozvo, iyo inokosha yemhando yeanoripiki inoshandiswa nevasayendisiti uye inobudiswa nevagadziri. Chigadzirwa chekupedzisira chinosungirirwa muhombodo semvura uye inopiwa kuburikidza nekuputika kwemavara.
Kufanana neRituxan, Gazyva inotarisira CD20 antigen. Iko CD20 antigen yakafanana nekaiti cheti-iyo ipuroteni yakaoma iripo pamusoro pemamwe masero, kusanganisira masero emachena eropa anozivikanwa seB-lymphocytes, kana masero B. Masero anonzi Immature B, anonzi masero e-pre-B , anewo CD20 antigen.
Apo obinutuzumab inosunga kuCD20, izvi zvinotungamirira kurufu uye kupera kusununguka kwemasero B. Zvinodaro nokuunganidza mamwe masero ezvirwere mumuviri, nekuita zvakananga zviratidzo zvekufa uye / kana kuita chimwe chinhu chinonzi complement cascade - mhando dzemakemikari zvinoshandiswa nemasimba ako ekushandisa, zvichiratidza kudiwa kwekutsvaga nekuparadza.
Gazyva yakasiyana sei neRituxan? Zvakanaka, maererano nevanoita zvinodhaka, Gazyva inofungidzirwa kuva nehuwandu hwekuita zvakananga sero rufu - chimwe chinhu chinonzi antibody-chinotarisira celtlar cytotoxicity (ADCC) - uye inokonzera basa guru mukushandurwa kwarwo mumuviri wemuviri kurwisa B-masero kana achienzaniswa ne-rituximab. Zvechokwadi, mumatauriro ekudzivirira, Gazyva yakakwira kusvika pakuwedzera kwemazana makumi matatu nemazana maviri muna ADCC yakaenzaniswa neRituxan. Gazyva yakagadzirisawo zviratidzo zvekufa mukati memasero eB inodzidza.
Migumisiro Yechiri
Kuchengetedzwa kweGazyva kwakaongororwa zvichibva kune 392 varwere vane indolent NHL, avo 81 muzana vakange vane follicular lymphoma.
Muvarwere vane follicular lymphoma, iyo yakawanda yakavhiringidzika yakaonekwa yakaenderana nehuwandu hwevanhu vakange vane indolent NHL.
Nzira dzakawanda dzinowanzoitwa neGazyva dzinopindirana, kupera kweropa rekuyera, kuora mwoyo, kuneta, kukwezva, chirwere chemahara, kudzivirira, fivha, low platelet zviyero, kurutsira, kuputika kwepamusoro kwekutapukisa, kupera kwechido, kuwirirana kana musuru, kurwadziwa, sinusitis, chikamu chemasero matsvuku cheropa, kushayiwa simba, uye urinary tract infection.
Kazhinji asi migumisiro yehupenyu inotyisidzira inorondedzerwa munechiremba 'kurondedzera ruzivo, dzimwe nguva kutora maitiro e "boxed warning". Nokuda kweGazyva, nyevero iyi inowanikwa inosanganisira ruzivo nezvemapirwere maviri ehutachiwana: Hepatitis B Virus (HBV) kuedzazve kuitika mune dzimwe nguva zvichiita kuti chiropa chakanyanya kuipa nekufa; uye JC virusi utachiona Progressive Multifocal Leukoencephalopathy (PML) inoguma norufu.
Nokuda kwekuchengetedzwa kwakakwana nekubudirira kwehuwandu hweGazyva mu follicular lymphoma, tapota ona Gazyva Kutsanangura Mashoko.
Sources:
1. Gazyva Kuchirondedzera Mashoko.
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3. Herter S, Herting F, Mundigl O, et al. Preclinical work of the type II CD20 antibody GA101 (obinutuzumab) yakaenzaniswa ne rituximab neatatumumab in vitro uye mu xenograft mhando. Mutanha weMol Ther . 2013; 12 (10): 2031-2042.
4. Klein C, Lammens A, Schäfer W, et al. Epitope kuwirirana kwe monoclonal antibodies inoronga CD20 uye ukama hwavo nekushanda. mAbs . 2013; 5 (1): 22-33.