2023 Juli:
Administrasi Pangan sarta Narkoba masihan persetujuan gancangan ka glofitamab-gxbm (Columvi, Genentech, Inc.) pikeun kambuh atanapi refractory diffuse lymphoma-sél B badag, teu disebutkeun dieusian (DLBCL, NOS) atanapi lymphoma-sél B badag (LBCL) timbul tina lymphoma follicular, sanggeus dua atawa leuwih garis terapi sistemik.
Glofitamab-gxbm, which is a bispecific CD20-directed CD3 T-cell engager, was studied in study NP30179 (NCT03075696), which was an open-label, single-arm, multicenter trial with 132 patients to test its effectiveness. Eighty percent of the patients had DLBCL, NOS that had come back or didn’t respond to treatment, and 20% had LBCL that came from follicular lymphoma. At least two lines of systemic treatment had been used before (median 3, range 2–7). Patients with current or past diseases or lymphomas of the central nervous system were not allowed to take part in the trial.
Ngagunakeun standar Lugano 2014, hiji Panitia Review Independen nempo laju respon obyektif (ORR) jeung durasi respon (DOR) pikeun angka kaluar kumaha ogé perlakuan digawé. ORR nyaéta 56% (95% CI: 47-65), sareng 43% jalma masihan jawaban lengkep. Responden anu dituturkeun nepi ka rata-rata 11.6 bulan, jadi median DOR ieu diprediksi janten 18.4 bulan (95% CI: 11.4, teu estimable). Perkiraan Kaplan-Meier pikeun DOR saatos 9 bulan nyaéta 68.5% (95% CI: 56.7, 80.3). Jumlah rata-rata waktos ngadangukeun deui nyaéta 42 dinten.
There is a Boxed Warning about sindrom sékrési sitokin (CRS), which can be very dangerous or even kill you. Other Warnings and Precautions include neurotoxicity, such as Immune Effector Cell-Associated Neurotoxicity (ICANS), major infections, and tumour flare. When the safety of 145 people with relapsed or refractory LBCL was looked at, 70% had CRS (Grade 3 or higher CRS, 4.1%), 4.8% had ICANS, 16% had major infections, and 12% had their tumours get worse.
Salian ti kecap lab, efek samping anu paling umum nyaéta CRS, nyeri otot sareng sendi, ruam, sareng kacapean. Paling Kelas 3 nepi ka 4 papanggihan lab (kira-kira 20%) éta tetes dina jumlah limfosit, fosfat, cacah neutrofil, sarta fibrinogen, sarta naék dina asam urat.
Saatos dosis tunggal 1,000 mg obinutuzumab dina Poé 1 Siklus 1 pikeun ngaleungitkeun sél B jaringan sirkulasi sareng limfoid, glofitamab-gxbm dirumuskeun ku infus intravena numutkeun jadwal dosis step-up: 2.5 mg dina Poé 8 Siklus 1 sareng 10 mg dina dinten ka-15 tina siklus 1 mg maksimum dina dinten ka-30 tina siklus 1 mg. 12 siklus. Panjang siklusna nyaéta 21 dinten. Kanggo inpormasi dosis lengkep, tingali inpormasi anu aya dina resep.
Glofitamab-gxbm ngan kedah dipasihkeun ku pagawe médis anu gaduh alat anu pas pikeun nanganan réaksi parna, sapertos CRS. Kusabab résiko CRS, pasien kedah cicing di rumah sakit salami sareng salami 24 jam saatos dosis léngkah munggaran (2.5 mg dina Poé 8 Siklus 1) sareng pikeun dosis léngkah kadua (10 mg dina Poé 15 Siklus 1) upami aya kelas CRS dina dosis 2.5 mg. Pasién anu ngagaduhan CRS Kelas 2 atanapi langkung luhur kalayan infus terakhirna kedah tetep di rumah sakit salami infus salajengna sareng salami 24 jam saatos réngsé.
The FDA Onkologi Center of Excellence nyetél Project Orbis, nu dipaké pikeun ngalakukeun ulikan ieu. Proyék Orbis masihan mitra asing cara pikeun ngirim sareng marios ubar onkologi dina waktos anu sami. Pikeun ulasan ieu, FDA damel sareng Swissmedic, dimana aplikasina ditingali.
View full prescribing information for Columvi.
