2023 Nov: Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) nyaéta antigen maturation B-sél B bispecific (BCMA) -diarahkeun CD3 T-sél engager anu dibéré persetujuan gancangan ku Administrasi Pangan sarta Narkoba for geus dewasa kalawan sababaraha myeloma relapsed atanapi refractory anu boga. ngagaduhan sahenteuna opat jalur terapi sateuacana, kalebet inhibitor proteasome, agén imunomodulator, sareng antibodi monoklonal anti CD38.
Dina MagnetisMM-3 (NCT04649359), penderita MM kambuh atanapi refractory anu tahan sahenteuna hiji inhibitor proteasome, hiji nginum obat immunomodulatory, sarta hiji antibodi anti CD38 kaasup kana open-label, single-arm, multi-puseur panalungtikan pikeun assess efficacy. Dina pendaptaran, pasien nyumponan kritéria anu ditetepkeun ku International Myeloma Working Group (IMWG) pikeun panyakit anu tiasa dideteksi.
Cara utama pikeun ngukur kumaha ogé hiji hal digarap éta laju respon obyektif (ORR) jeung durasi respon (DOR), nu kapanggih ku hiji bebas, review sentral dilolongan nuturkeun tungtunan IMWG. Salapan puluh tujuh pasien anu henteu kantos nampi terapi anu diarahkeun ku BCMA sateuacanna tapi ngagaduhan sahenteuna opat jalur terapi sateuacana-sambetan proteasome, ubar immunomodulatory, sareng antibodi monoklonal anti CD38-nyiptakeun populasi efficacy primér. Salapan puluh tujuh pasien (95% CI: 47.3%, 67.7%) dina dosis anu disarankeun ngagaduhan ORR 57.7%. The median DOR diantara responders teu ngahontal sanggeus nurutan-up of 11.1 bulan (95% CI: 12 bulan, teu ngahontal). 90.4% (95% CI: 78.4%, 95.9%) éta laju DOR dina genep bulan, sarta 82.3% (95% CI: 67.1%, 90.9%) dina salapan bulan.
Elranatamab-bcmm’s prescribing information includes a Boxed Warning for neurologic damage, including immune effector cell-associated neurotoxicity (ICANS), and sindrom sékrési sitokin (CRS), which can be deadly or life-threatening. Elranatamab-bcmm was administered to patients at the prescribed dose; of them, 58% experienced CRS, 59% experienced neurologic damage, and 3.3% experienced ICANS. In 0.5% of individuals, grade 3 CRS happened, while in 7% of cases, grade 3 or 4 neurologic toxicity happened. Elranatamab-bcmm is only accessible through a restricted programme under a Risk Evaluation and Mitigation Strategy (REMS), known as the ELREXFIO REMS, due to the risks of CRS and neurologic toxicity, including ICANS.
CRS, kacapean, réspon situs suntikan, diare, inféksi saluran pernapasan luhur, teu ngarareunah muskuloskeletal, pneumonia, turun napsu, ruam, batuk, seueul, sareng pyrexia mangrupikeun efek samping anu paling sering (≥20%). Turunna hémoglobin, neutrofil, trombosit, limfosit, sareng sél getih bodas mangrupikeun abnormalitas laboratorium Kelas 3 dugi ka 4 anu paling sering (≥20%).
Dosis perlakuan munggaran 76 mg dina Poé 8 dituturkeun ku "step-up dosis 1" tina 12 mg dina Poé 1 jeung "step-up dosis 2" tina 32 mg dina Poé 4. The dianjurkeun elranatamab-bcmm dosages nyaéta kieu. : 76 mg mingguan ngaliwatan Minggu 24. Interval dosage kudu robah jadi unggal dua minggu pikeun pasien anu geus nyokot elranatamab-bcmm salila sahenteuna 24 minggu, némbongkeun réspon parsial, atawa hadé, sarta réspon sustained salila sahenteuna dua bulan. Elranatamab-bcmm tiasa dicandak dugi ka panyakit parah atanapi tingkat karacunan janten teu kaampeuh.
