Yuli 2023: Cibiyar Abinci da Drug ta ba da izini ga epcoritamab-bysp (Epkinly, Genmab US, Inc.) don sake dawowa ko refractory yaduwa babban lymphoma B-cell (DLBCL) ba in ba haka ba, ciki har da DLBCL wanda ya fito daga lymphoma maras kyau, da kuma babban darajar B-cell lymphoma bayan layi biyu ko fiye na tsarin farfadowa.
Epcoritamab-bysp, CD20-directed CD3 T-cell engaged, an gwada shi a cikin EPCORE NHL-1 (NCT03625037), alamar buɗewa, ƙungiyoyi masu yawa, multicenter, nazarin hannu guda ɗaya tare da marasa lafiya tare da relapsed ko refractory B-cell lymphoma. Yawan ingancin ya ƙunshi marasa lafiya 148 tare da sake dawowa ko DLBCL mai juyayi, ba a kayyade ba, ciki har da DLBCL daga lymphoma maras kyau da kuma babban darajar B-cell lymphoma, bayan layi biyu ko fiye na tsarin tsarin, ciki har da akalla daya anti-CD20 monoclonal antibody-dauke da far.
Kwamitin Bita mai zaman kansa ya yi amfani da ma'aunin Lugano 2014 don gano ƙimar amsa gabaɗaya (ORR), wanda shine ma'aunin tasiri. ORR shine 61% (95% CI: 53-69), kuma 38% na marasa lafiya sun sami cikakkiyar amsa. Tare da tsaka-tsaki mai biyo baya na watanni 9.8 don masu amsawa, tsawon lokacin da aka ƙaddara (DOR) shine watanni 15.6 (95% CI: 9.7, ba a kai ba).
The prescription information has a Boxed Warning about cytokine saki ciwo (CRS), which can be serious or even kill you, and immune effector cell-associated neurotoxicity syndrome (ICANS), which can also be serious or kill you. Among the warnings and measures, infections and cytopenias are mentioned. 51% of the 157 people with relapsed or refractory large B-cell linzoma who took the suggested dose of epcoritamab-bysp had CRS, 6% had ICANS, and 15% had serious infections. 37% of people with CRS had Grade 1, 17% had Grade 2, and 2.5% had Grade 3. 4.5% of ICANS cases were Grade 1, 1.3% were Grade 2, and 0.6% were Grade 5.
Epcoritamab-bysp ya kamata ma'aikaci mai horarwa ne kawai ya ba da tallafin likita mai dacewa don magance munanan halayen kamar CRS da ICANS. Saboda damar CRS da ICANS, mutanen da suka dauki 48 MG a ranar 15 na Cycle 1 ya kamata su zauna a asibiti na tsawon sa'o'i 24.
Abubuwan da ke faruwa a mafi yawan lokuta (kimanin 20%) sune CRS, gajiya, jin zafi a tsokoki da haɗin gwiwa, halayen da aka yi a wurin allura, zazzabi, ciwon ciki, tashin zuciya, da gudawa. Mafi yawan abubuwan da suka fi dacewa a cikin Lab 3 zuwa 4 (10%) sune ƙananan adadin lymphocytes, neutrophils, farin jini, haemoglobin, da platelets.
Tsarin magani da aka ba da shawarar shine a ba da epcoritamab-bysp subcutaneously kowane kwanaki 28 har sai cutar ta yi muni ko illolin da ke tattare da ita sun yi muni sosai. A cikin Cycle 1, adadin da aka ba da shawarar shine 0.16 MG a ranar 1, 0.80 MG a ranar 8, da 48 MG akan Ranaku 15 da 22. Wannan yana biye da ƙayyadaddun kashi na 48 MG kowane mako don Cycles 2 ta hanyar 3, kowane mako don Cycles 4 ta hanyar 9, sa'an nan kuma kowane mako hudu a kan sake zagayowar rana.
View full prescribing information for Epkinly.
