Gazyva (Obinutuzumab) ndi mankhwala omwe ali ofanana ndi Rituxan (rituximab) ndipo akufufuzidwa pa mitundu yambiri ya khansa ya magazi, kuphatikizapo maphunziro ochuluka a zachipatala omwe si a Hodgkin's lymphoma (NHL). Monga Rituxan, Gazyva imagwiritsidwa ntchito pamodzi ndi chemotherapy pofuna kuchiza khansa zina zamagazi. Genentech ndi Roche analemba kuti pali maphunziro ochulukirapo ochulukirapo poyerekeza ndi obinutuzumab ndi rituximab muzitsulo zopanda malire zomwe sizomwe zimakhala ndi Hodgkin's lymphoma komanso kuti zikhale zazikulu kwambiri B-cell lymphoma.
Gazyva tsopano ndi FDA-yovomerezeka kuti ntchito kwa odwala ena ndi follicular lymphoma, kuphatikizapo itakhazikitsidwa ntchito mu chronic lymphocytic leukemia, kapena CLL. Kwa CLL, Gazyva imagwirizanitsidwa ndi chlorambucil; chifukwa cha follicular lymphoma, Gazyva imaphatikizidwa ndi bendamustine.
About Follicular Lymphoma
Ngakhale kuti ndilo lofala kwambiri la lymphoma, follicular lymphoma ndilopakati mwa mitundu yomwe imapezeka kuti imakhala ndi lymphoma. Magulu awiri a lymphoma ndiwo Hodgkin ndi omwe si a Hodgkin's lymphoma. Follicular lymphoma ndi mtundu wosakhala wa Hodgkin ndipo ndi wamba wambirimbiri wamphongo (NHL) omwe amadzipweteka kwambiri, omwe amakula, omwe sali a Hodgkin.
Ngakhale kuti ikukula mofulumira, imakhalabe khansara yosachiritsika yomwe imakhala yovuta kwambiri kuchiza nthawi iliyonse ikabwerera. Mapulogalamu a Follicular lymphoma amakamba pafupifupi 1 miliyoni pa NHL ku United States, komwe akuti anthu oposa 14,000 atsopano amapezeka mu 2015.
Pamene odwala ambiri amatha kusunga malungo, mankhwala atsopano amalandiridwa.
Gazyva ya Lymphoma ya Follicular
"Anthu omwe ali ndi follicular lymphoma omwe amadwala matendawa kapena amavutika ngakhale atakhala ndi mankhwala a Rituxan amafunikira zina zambiri chifukwa matendawa amakhala ovuta kuchiza nthawi iliyonse," anatero Sandra Horning, MD, wamkulu wa zachipatala komanso a Global Product. Development.
"Gazyva kuphatikizapo bendamustine imapereka chithandizo chamankhwala chatsopano chomwe chingagwiritsidwe ntchito pambuyo pobwezeretsa kuchepetsa kwambiri chiopsezo cha kupita patsogolo kapena kufa."
Kuvomereza kwa FDA Gazyva kunachokera ku zotsatira za kafukufuku wa Phase III GADOLIN, zomwe zikuwonetsa kuti, anthu omwe ali ndi follicular lymphoma omwe matenda awo amapita mkati kapena mkati mwa miyezi isanu ndi umodzi yothandizidwa ndi Rituxan, Gazyva plus bendamustine ndi Gazyva okha anasonyezera 52 Peresenti ya kuchepa kwa chiopsezo cha matenda owonjezereka kapena imfa (kupulumuka kwapanda moyo, PFS), poyerekeza ndi bendamustine okha.
Momwe Gazyva Imagwirira Ntchito
Gazyva, monga Rituxan, ndi anti-monoclonal antibody. Ndikutanthauza kuti ndi mtundu wapadera wa anti-antibody wopangidwa ndi asayansi ndipo amapangidwa ndi opanga. Chogwiritsidwa ntchito chomaliza chimapachikidwa m'thumba ngati madzi ndipo amaperekedwa kudzera mwa kulowetsedwa.
Monga Rituxan, Gazyva imalimbikitsa CD20 antigen. CD20 antigen ili ngati chizindikiro chodziwika - ndi mapuloteni ovuta omwe ali pamtunda wa maselo ena, kuphatikizapo maselo oyera a m'magazi omwe amadziwika kuti B-lymphocytes, kapena maselo a B. Maselo aang'ono a B, omwe amatchedwa maselo a Pre-B , amakhalanso ndi CD20 antigen.
Pamene obinutuzumab imamangiriza ku CD20, izi zimawatsogolera ku imfa ndi kutaya kutsegulidwa kwa maselo B. Zimatero polemba maselo ena ammadzimadzi kuti agwire ntchito, poyambitsa zizindikiro za imfa ndi / kapena kuyambitsa chinthu chomwe chimatchedwa kuti complement cascade - njira zamagetsi zomwe thupi lanu limagwiritsa ntchito, kusonyeza kufunika kofuna ndi kuwononga.
Kodi Gazyva imasiyana bwanji ndi Rituxan? Malingana ndi ogulitsa mankhwala, Gazyva akuganiza kuti ali ndi mphamvu yowonjezera yopangitsa selo yeniyeni kufa - chinachake chotchedwa cytotoxicity (ADCC) yotchedwa antibody-dependent cell (ADCC) - ndipo imapangitsa ntchito yaikulu momwe ikugwiritsira ntchito chitetezo cha mthupi kuti chiteteze B-maselo poyerekeza ndi rituximab. Ndipotu, pamaphunziro apadera, Gazyva inapitilira kuwonjezereka kwa ADCC kokwana 35 poyerekeza ndi Rituxan. Gazyva inavomerezanso zizindikiro za imfa m'maselo a B m'maphunziro oyambirira.
Zotsatira Zotsatira
Kutetezeka kwa Gazyva kunayesedwa kuchokera pa 392 odwala omwe ali ndi NHL osadziwika, omwe 81 peresenti anali ndi follicular lymphoma.
Odwala ndi follicular lymphoma, zotsatira zoyipa zomwe zimawoneka zinali zogwirizana ndi chiwerengero cha anthu omwe anali ndi NHL.
Zotsatira zofala kwambiri za Gazyva ndizokakamizidwa, kuchepa, chifuwa, kutsekula m'mimba, kudzimbidwa, kutentha thupi, chiwerengero chochepa cha mapiritsi, kusanza, kupweteka kwapakati pamtenda, kuchepa kwa njala, kupweteka kwa thupi, minofu, sinusitis, Khungu lofiira la magazi, limafooka kwambiri, komanso matenda opatsirana.
Kawirikawiri koma zotsatira zoopsa zowopsa zimayikidwa mu madokotala akufotokozera, nthawi zina kutenga mawonekedwe a "boxed warning". Kwa Gazyva, machenjezo awa ali ndi zidziwitso zokhudzana ndi kachilombo ka HIV: Matenda a Hepatitis B (HBV) nthawi zina amachititsa kuwonongeka kwa chiwindi ndi imfa; ndi JC HIV matenda Progressive Multifocal Leukoencephalopathy (PML) kuti imfa.
Kuti mudziwe zambiri zokhudza chitetezo cha Gazyva mu follicular lymphoma, chonde onani Gazyva Kulongosola Information.
Zotsatira:
1. Gazyva Kulongosola Zomwe Mukudziwa.
2. Mössner E, Brünker P, Moser S, et al. Kuonjezera mphamvu ya anti-antibiotic CD20 kudzera mu injini ya anti-anti-CD20 watsopano wotsutsana ndi CD20 ndi mphamvu yeniyeni yeniyeni yowonongeka ya B-cell cytotoxicity. Magazi . 2010; 115 (22): 4393-4402.
3. Herter S, Herting F, Mundigl O, et al. Ntchito yowonongeka ya mtundu wa II CD anti-CD1 GA101 (obinutuzumab) poyerekeza ndi rituximab ndiatumumab mu vitro komanso xenograft mitundu. Mayi khansa ya khansa . 2013; 12 (10): 2031-2042.
4. Klein C, Lammens A, Schäfer W, et al. Zophatikizana za ma antibodies monoclonal omwe akuwongolera CD20 ndi ubale wawo ndi ntchito. mAbs . 2013; 5 (1): 22-33.