EyeThupha21,I-bispecific T cell engager, i-epcoritamab, inikwe uphononongo oluphambili yiZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA). Imvume ijoliswe kwizigulana zabantu abadala abane-relapse okanye i-refractory follicular lymphoma (FL), icandelo elifunekayo kakhulu le-B cell malignancies.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Malunga ne-Epcoritamab
I-Epcoritamab yi-antibody ye-IgG1-bispecific eyenziwe kusetyenziswa ubuchwepheshe be-DuoBody obuyi-Genmab kwaye isetyenziswa ngaphantsi kwesikhumba. Iteknoloji ye-DuoBody-CD3 ye-Genmab yenzelwe ukulawula iiseli ze-T ezine-cytotoxic ngokukhetha ukuze zikhuphe impendulo yomzimba kwiintlobo zeeseli ekujoliswe kuzo. I-Epcoritamab yenzelwe ukubopha ngaxeshanye kwi-CD3 kwiiseli ze-T kunye ne-CD20 kwiiseli ze-B kwaye ibangela ukubulawa kweeseli ze-CD20+ okubangelwa ziiseli ze-T.
Malunga neFollicular Lymphoma (FL)
I-FL idla ngokuba luhlobo olungasebenziyo (okanye olukhula kancinci) lwe-non-Hodgkin's lymphoma (NHL) oluvela kwi-B-lymphocytes kwaye lolona hlobo lwesibini oluqhelekileyo lwe-NHL olubandakanya i-20-30 yepesenti yazo zonke iimeko. Malunga ne-15,000 yabantu iba ne-FL minyaka le kwi-USii kwaye ithathwa njengenganyangekiyo ngonyango olusemgangathweni lwangoku. Iigulane zihlala ziphinda zibuyele kwaye, ngokubuyela ngakunye ukuphinda zibuyele umva, ukukhululwa kunye nexesha lonyango olulandelayo lifutshane. Ngokuhamba kwexesha, utshintsho luye kwi-diffuse large B-cell lymphoma (DLBCL), uhlobo oluhlaselayo lwe-NHL olunxulunyaniswa neziphumo ezimbi zokusinda, lunokwenzeka kwizigulane ezingaphezu kwe-25 ze-FL.
I-EPCORE FL-1 (NCT05409066) luvavanyo oluvulelekileyo lweSigaba sesi-3 lokuvavanya ukhuseleko kunye nokusebenza kakuhle kwe-epcoritamab kunye ne-rituximab kunye ne-lenalidomide (R2) xa kuthelekiswa ne-R2 yodwa kwizigulane ezine-relapse/refractory (R/R) follicular lymphoma (FL).
Nge-7 ka-Agasti,I-Genmab A/Sibhengeze iziphumo ezilungileyo zovavanyo lweSigaba sesi-3 se-EPCORE FL-1 oluvavanya i-epcoritamab engaphantsi komzimba, i-antibody ye-bispecific, kunye ne-rituximab kunye ne-lenalidomide (R®2) xa kuthelekiswa ne-R2 yodwa yokunyanga izigulane ezindala ezine-relapse or refractory (R/R) follicular lymphoma (FL). Olu phononongo lufikelele kwi-dual primary endpoints of whole response rate (ORR, p-value <0.0001) kunye ne-progressive-free survival (PFS, HR 0.21, p-value <0.0001), ebonisa umahluko obalulekileyo ngokwezibalo kunye nowentsingiselo yeklinikhi kuzo zombini i-endpoints, kunciphisa umngcipheko wokuqhubela phambili kwesifo okanye ukufa nge-79%.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Septemba-05-2025