Gazyva (Obinutuzumab) ke moriana o tšoanang le Rituxan (rituximab) 'me o ntse o batlisisoa ka mefuta e sa tšoaneng ea kankere ea mali, ho akarelletsa le lithuto tse ngata tsa bongaka ho e seng Hodgkin's lymphoma (NHL). Joaloka Rituxan, Gazyva e sebelisoa hammoho le chemotherapy bakeng sa phekolo ea mafu a mang a kankere ea mali. Batho ba nang le lithethefatsi Genentech le Roche tlaleho ea hore ho na le liphuputso tse ngata tse tsoelang pele tse bapisang obinutuzumab le rituximab tse sa sebetsaneng le li-non-Hodgkin's lymphoma le bakeng sa B-cell lymphoma e kholo.
Hona joale Gazyva e lumelloa ke FDA hore e sebelisoe ho bakuli ba bang ba nang le follicular lymphoma, ho phaella moo e sebelisitsoeng ho boloka lefu la kankere ea lefu la lymphocytic kapa CLL. Bakeng sa CLL, Gazyva e kopantsoe le chlorambucil; bakeng sa follicular lymphoma, Gazyva e kopantsoe le bendamustine.
About Follicular Lymphoma
Le hoja e se mofuta o tloaelehileng haholo oa lymphoma, follicular lymphoma e na le mefuta e mengata e tloaelehileng ea lymphoma. Likarolo tse peli tsa motheo tsa lymphoma ke Hodgkin le e seng Hodgkin's lymphoma. Follicular lymphoma ke mofuta oa se seng oa Hodgkin 'me ke oona o tloaelehileng ka ho fetisisa oa li-lymphomas (NHL) tsa indolent, kapa ea ho lieha ho hōla, e seng ea Hodgkin.
Le hoja e ntse e hōla butle, e lula e le kankere e sa phekoleheng e bang thata ho e phekola nako le nako ha e khutla. Litlaleho tsa follicular lymphoma tse ka bang likarolo tse hlano tsa NHL United States, moo ho hakantsoeng hore linyeoe tse ncha tse fetang 14 000 li tla fumanoa ka 2015.
Ha bakuli ba bangata ba atleha ho boloka boloetse bo hlephileng, mekhoa e mecha ea phekolo e amoheloa ka ho khetheha.
Gazyva bakeng sa Lymphoma ea Follicular
"Batho ba nang le follicular lymphoma bao boloetse ba bona bo hlahang kapa bo ntseng bo mpefala ho sa tsotellehe phekolo ea mefuta ea Rituxan e hloka mefuta e mengata hobane lefu lena le thatafalloa ke ho phekola nako le nako ha le khutla," ho boletse Sandra Horning, MD, ngaka ea ka sehloohong le lefapha la Global Product. Ntlafatso.
"Gazyva hammoho le bendamustine e fana ka khetho e ncha e ka sebelisoang ka mor'a ho khutlela morao ho fokotsa kotsi ea tsoelo-pele kapa lefu."
Tumelo ea FDA ea Gazyva e ne e itšetlehile ka liphello tsa phuputso ea Phase III ea GADOLIN, e bontšang hore, ho batho ba nang le lymphoma ea follicular eo boloetse ba bona bo ileng ba tsoela pele nakong ea pele kapa ka mor'a likhoeli tse tšeletseng tsa phekolo ea Rituxan, Gazyva hammoho le bendamustine e lateloa ke Gazyva feela e bontšitse 52 ho fokotseha ha karolo ea lekholong ha kotsi ea ho kula ho mpefala kapa lefu (ho pholoha ha bolokolohi bo sa tsoaneng, PFS), ho bapisoa le bendamustine feela.
Kamoo Gazyva e Sebetsang Kateng
Gazyva, e kang Rituxan, ke antibody e monoclonal. Ke hore, ke mofuta o ikhethang oa anti-opeose o entsoeng ke bo-rasaense le o hlahisoang ke bahlahisi. Sehlahisoa sa ho qetela se fanyehoa ka mokotleng e le metsi 'me se fanoe ka ho kenngoa ha methapo.
Joaloka Rituxan, Gazyva e hlasela antigen ea CD20. CD20 antigen e tšoana le letšoao le khethollang - ke ntho e rarahaneng ea protheine e teng holim'a lisele tse ling, ho kenyelletsa le lisele tse tšoeu tsa mali tse tsejoang e le B-lymphocyte, kapa lisele tsa B. Lisele tse nyenyane tsa B, tse bitsoang lisele tsa pele ho B , li boetse li na le antigen ena ea CD20.
Ha obinutuzumab e tlama ho CD20, sena se lebisa lefung mme se qhala ho buloa ha lisele tsa B. E etsa joalo ka ho ngolisa lisele tse ling tsa 'mele tsa ho itšireletsa mafung ho etsa mosebetsi, ka ho hlahisa lipontšo tsa lefu ka ho toba le / kapa ho kenya ntho e bitsoang complement cascade - phetoho ea lik'hemik'hale ea' mele ea hau ea ho itšireletsa mafung, e bontšang tlhokahalo ea ho batla le ho senya.
Gazyva e fapana joang le Rituxan? Hantle, ho latela baetsi ba lithethefatsi, Gazyva ho nahanoa hore e na le bokhoni bo eketsehileng ba ho kenyelletsa seleng e tobileng lefu - ntho e bitsoang e-anti-motho ea itšetlehileng ka cytotoxicity (ADCC) - mme e etsa hore mosebetsi o moholo o sebetsane le hore na o sebelisa mokhoa ofe oa ho itšireletsa mafung a 'mele ho hlasela B-lisele ha li bapisoa le rituximab. Ha e le hantle, liphuputsong tse tobileng, Gazyva e fane ka keketseho ea 35 ho ADCC ha e bapisoa le Rituxan. Gazyva e ile ea boela ea lumella lipontšo tsa lefu ka har'a lisele tsa B ka lithuto tsa pele.
Litla-morao
Tšireletseho ea Gazyva e ile ea hlahlojoa ho thehiloe ho bakuli ba 392 ba nang le NHL ea indolent, eo karolo ea 81 lekholong e neng e e-na le follicular lymphoma.
Bakeng sa bakuli ba nang le follicular lymphoma, litla-morao tse tloaelehileng tse ileng tsa bonoa li ne li lumellana le batho bohle ba nang le NHL ea indolent.
Litla- morao tse tloaelehileng ka ho fetisisa tsa Gazyva ke liketso tsa ho fokotsa tšoaetso, litefello tse fokolang tsa lisele tsa mali, ho ferekanya, mokhathala, ho khohlela, letšollo, ho phalla, feberu, lipalo tse tlaase tsa platelet, ho hlatsa, tšoaetso e phahameng ea matšoafo, ho fokotsa takatso ea lijo, bohloko bo kopantsoeng kapa ba mesifa, sinusitis, ho ba le lisele tse nyenyane tsa mali tse khubelu, bofokoli bo akaretsang le tšoaetso ea moriana.
Nakoana empa litla-morao tse sokelang bophelo li tlalehoa ka ho fana ka tlhahisoleseding ea lingaka, ka nako e 'ngoe li nka mofuta oa "temoso ea boxed". Bakeng sa Gazyva, temoso ena e kenyelletsoeng e kenyelletsa tlhahisoleseding e mabapi le mafu a mabeli a tšoaetso ea kokoana-hloko: Ho tsosolosa ha Hepatitis B Virus (HBV) maemong a mang ho baka tšenyo e matla ea sebete le lefu; le JC kokoana-hloko ea tšoaetso Progressive Multifocal Leukoencephalopathy (PML) e fellang ka lefu.
Bakeng sa boitsebiso bo feletseng ba polokeho le katleho ea Gazyva ho follicular lymphoma, ka kopo sheba litaba tsa Gazyva Ho hlalosa.
Lisebelisoa:
1. Gazyva Ho hlahisa boitsebiso.
2. Mössner E, Brünker P, Moser S, le al. Ho eketsa ts'ebetso ea phekolo ea anti-antibody (CD20) ka theknoloji ea moriana o mocha oa anti-CD20 oa mofuta o mocha o nang le motlakase oa motlakase oa B-cell cytotoxicity. Mali . 2010; 115 (22): 4393-4402.
3. Herter S, Herting F, Mundigl O, et al. Ketsahalo ea pele ho mefuta ea mofuta oa II CD anti-CD1 GA101 (obinutuzumab) ha e bapisoa le rituximab le yaatumumab in vitro le ka xenograft mehlala. Ther Cancer Ther . 2013; 12 (10): 2031-2042.
4. Klein C, Lammens A, Schäfer W, et al. Li-epitope li sebetsana le li-antibodies tsa monoclonal tse amanang le CD20 le kamano ea bona le thepa e sebetsang. mAbs . 2013; 5 (1): 22-33.