Julayi 2023: I-Food and Drug Administration inikeze ukugunyazwa okusheshisiwe ku-epcoritamab-bysp (Epkinly, Genmab US, Inc.) yokusabalalisa kabusha i-B-cell lymphoma (DLBCL) enkulu engashiwongo ngenye indlela, okuhlanganisa i-DLBCL ephuma ku-indolent lymphoma, kanye ne-B-cell lymphoma yezinga eliphezulu ngemva kwemigqa emibili noma ngaphezulu yokwelapha okuhlelekile.
I-Epcoritamab-bysp, i-CD20-directed CD3 T-cell engager bispecific CD1-directed, ihlolwe ku-EPCORE NHL-03625037 (NCT148), ilebula evulekile, enamaqoqo amaningi, ehlanganisa izindawo eziningi, isifundo sengalo eyodwa neziguli ezine-B-cell lymphoma ebuyele emuva noma ephikisayo. Isibalo esisebenzayo sakhiwe iziguli ezingu-20 ezine-DLBCL ebuyele emuva noma ephikisayo, okungacaciswanga ngenye indlela, okuhlanganisa i-DLBCL evela ku-indolent lymphoma kanye ne-high-grade B-cell lymphoma, ngemva kwemigqa emibili noma ngaphezulu yokwelashwa kwe-systemic, okuhlanganisa okungenani ukwelashwa okukodwa kwe-anti-CDXNUMX monoclonal antibody-containing.
IKomidi Lokubuyekeza Elizimele lasebenzisa indlela ye-Lugano 2014 ukuze lithole inani lokuphendula eliphelele (ORR), okwakuyisilinganiso esibalulekile sokusebenza ngempumelelo. I-ORR yayingu-61% (95% CI: 53-69), kanti ama-38% eziguli abe nokusabela okuphelele. Ngokulandelwa okumaphakathi kwezinyanga eziyi-9.8 kwabaphendulayo, ubude besikhathi sokuphendula (DOR) obuqageliwe bebuyizinyanga eziyi-15.6 (95%CI: 9.7, azifinyelelwanga).
The prescription information has a Boxed Warning about i-cytokine release syndrome (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 i-lymphoma 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.
I-Epcoritamab-bysp kufanele inikezwe kuphela isisebenzi sezokwelapha esiqeqeshiwe esinokwesekwa okufanele kwezokwelapha ukuze sibhekane nokusabela okubucayi okufana ne-CRS ne-ICANS. Ngenxa yethuba le-CRS ne-ICANS, abantu abathatha ama-48 mg ngosuku lwe-15 Lomjikelezo 1 kufanele bahlale esibhedlela amahora angu-24.
Imiphumela engemihle eyenzeka kaningi (cishe ama-20%) kwakuyi-CRS, ukukhathala, ubuhlungu bemisipha namalunga, ukusabela endaweni yomjovo, umkhuhlane, ubuhlungu besisu, isicanucanu, kanye nesifo sohudo. Ukungajwayelekile kwelebhu yeBanga lesi-3 ukuya kwelesi-4 (10%) kwakuyinani eliphansi lama-lymphocyte, ama-neutrophils, amangqamuzana egazi amhlophe, i-hemoglobin, nama-platelet.
Uhlelo lokwelapha oluphakanyisiwe ukunikeza i-epcoritamab-bysp ngaphansi kwesikhumba njalo ezinsukwini ezingama-28 kuze kube yilapho isifo siba sibi kakhulu noma imiphumela engemihle ibe mibi kakhulu. Ku-Cycle 1, umthamo ophakanyisiwe ngu-0.16 mg ngosuku lwe-1, i-0.80 mg ngosuku lwe-8, kanye ne-48 mg ngezinsuku ze-15 ne-22. Lokhu kulandelwa umthamo ohleliwe we-48 mg njalo ngeviki kuma-Cycles 2 kuya ku-3, njalo kwelinye isonto nge-Cycles 4 kuya ku-9, bese kuthi njalo emavikini amane ngoSuku loku-1 lomjikelezo.
View full prescribing information for Epkinly.
