2023 Juli: Administrasi Pangan sarta Narkoba masihan persetujuan gancangan ka epcoritamab-bysp (Epkinly, Genmab AS, Inc.) pikeun kambuh atanapi refractory diffuse lymphoma-sél B badag (DLBCL) teu disebutkeun dieusian, kaasup DLBCL nu asalna ti lymphoma indolent, sarta lymphoma-sél B-grade tinggi sanggeus dua atawa leuwih garis terapi sistemik.
Epcoritamab-bysp, CD20-diarahkeun CD3 T-sél engager bispecific, ieu diuji di EPCORE NHL-1 (NCT03625037), hiji labél kabuka, multi-cohort, multiséntral, ulikan single-panangan kalayan penderita relapsed atanapi refractory lymphoma B-sél. Populasi efficacy diwangun ku 148 penderita DLBCL relapsed atanapi refractory, teu disebutkeun dieusian, kaasup DLBCL ti lymphoma indolent na lymphoma-sél B-grade tinggi, sanggeus dua atawa leuwih garis terapi sistemik, kaasup sahanteuna hiji anti CD20 monoclonal antibodi-ngandung terapi.
Panitia Tinjauan Independen nganggo kriteria Lugano 2014 pikeun ngémutan tingkat réspon sakabéh (ORR), anu mangrupikeun ukuran konci éféktivitas. ORR nyaéta 61% (95% CI: 53-69), sareng 38% pasien ngagaduhan réaksi lengkep. Kalawan median nurutan-up 9.8 bulan pikeun responders, anu projected durasi median respon (DOR) éta 15.6 bulan (95% CI: 9.7, teu ngahontal).
The prescription information has a Boxed Warning about sindrom sékrési sitokin (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 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.
Epcoritamab-bysp ngan kudu dibikeun ku pagawe médis terlatih jeung rojongan médis katuhu pikeun nungkulan réaksi serius kawas CRS na ICANS. Kusabab kasempetan CRS sareng ICANS, jalma anu nyandak 48 mg dina Poé 15 Siklus 1 kedah cicing di rumah sakit salami 24 jam.
Efek samping anu paling sering kajadian (kira-kira 20%) nyaéta CRS, kacapean, nyeri otot sareng sendi, réaksi di tempat suntikan, muriang, nyeri beuteung, seueul, sareng diare. Abnormalitas lab Kelas 3 nepi ka 4 anu paling umum (10%) nyaéta jumlah limfosit, neutrofil, sél getih bodas, hémoglobin, sareng trombosit anu langkung handap.
Rencana perlakuan anu disarankeun nyaéta masihan epcoritamab-bysp subcutaneously unggal 28 dinten dugi ka panyakit janten parah atanapi efek samping parah teuing. Dina Siklus 1, dosis anu disarankeun nyaéta 0.16 mg dina Poé 1, 0.80 mg dina Poé 8, sareng 48 mg dina Poé 15 sareng 22. Ieu dituturkeun ku dosis tetep 48 mg unggal minggu pikeun Siklus 2 dugi ka 3, unggal minggu sanés pikeun Siklus 4 dugi ka 9, teras unggal opat minggu dina siklus Poé 1.
View full prescribing information for Epkinly.
