Ogasiti21,Katemera wa bispecific T cell engager, epcoritamab, wapatsidwa mwayi wowunikanso ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA). Chivomerezochi chikuyang'ana odwala akuluakulu omwe ali ndi relaxed or refractory follicular lymphoma (FL), gulu la khansa ya maselo a B lomwe likufunika kwambiri.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
About Epcoritamab
Epcoritamab ndi antibody ya IgG1-bispecific yopangidwa pogwiritsa ntchito ukadaulo wa Genmab wa DuoBody ndipo imaperekedwa pansi pa khungu. Ukadaulo wa Genmab wa DuoBody-CD3 wapangidwa kuti utsogolere maselo a T omwe ali ndi poizoni kuti alimbikitse chitetezo cha mthupi ku mitundu ya maselo omwe akufuna. Epcoritamab yapangidwa kuti igwirizane ndi CD3 pa maselo a T ndi CD20 pa maselo a B nthawi imodzi ndipo imayambitsa kuphedwa kwa maselo a CD20+ kudzera mu T-cell.
Zokhudza Follicular Lymphoma (FL)
FL nthawi zambiri ndi mtundu wa non-Hodgkin's lymphoma (NHL) womwe umachokera ku ma B-lymphocyte ndipo ndi mtundu wachiwiri wofala kwambiri wa NHL womwe umakhala ndi 20-30 peresenti ya milandu yonse. Anthu pafupifupi 15,000 amadwala FL chaka chilichonse ku USii ndipo imaonedwa kuti ndi yosachiritsika ndi njira zamakono zochiritsira.iii Odwala nthawi zambiri amabwereranso ndipo, akabwereranso nthawi iliyonse, kuchira ndi nthawi yochira kumakhala kochepa.iv Pakapita nthawi, kusintha kukhala kufalitsa large B-cell lymphoma (DLBCL), mtundu woopsa wa NHL wokhudzana ndi zotsatira zoyipa za kupulumuka, kumatha kuchitika mwa odwala oposa 25 peresenti a FL.
EPCORE FL-1 (NCT05409066) ndi mayeso otseguka a Gawo 3 kuti awone chitetezo ndi mphamvu ya epcoritamab kuphatikiza rituximab ndi lenalidomide (R2) poyerekeza ndi R2 yokha mwa odwala omwe ali ndi relaxed/refractory (R/R) follicular lymphoma (FL).
Ogasiti 7,Genmab A/Sadalengeza zotsatira zabwino za mayeso a Gawo 3 la EPCORE FL-1 omwe adayesa subcutaneous epcoritamab, antibody ya bispecific, kuphatikiza ndi rituximab ndi lenalidomide (R®2) poyerekeza ndi R2 yokha yochizira odwala akuluakulu omwe ali ndi relaxed or refractory (R/R) follicular lymphoma (FL). Kafukufukuyu adakwaniritsa ma endpoints ake awiri oyambira a kuchuluka kwa mayankho onse (ORR, p-value <0.0001) ndi kupulumuka kopanda kupita patsogolo (PFS, HR 0.21, p-value <0.0001), kuwonetsa kusiyana kwakukulu komanso kofunikira kuchipatala m'ma endpoints onse awiri, kuchepetsa chiopsezo cha kupita patsogolo kwa matenda kapena imfa ndi 79%.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Sep-05-2025