Nov 2023; Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) est maturatio bispecialis B-cellula antigenii (BCMA) directa CD3 T-cellula sponsionis quae a Cibus et medicamentis Administrationis adultorum cum relapso vel refractorio multiplex myeloma probatio accelerata data est. quattuor saltem priores lineas therapiae habuit, quae comprehenderunt proteasome inhibitorem, agentem immunomodulatorium, et anti-CD38 anticorpum monoclonale.
In MagnetisMM-3 (NCT04649359), aegros relapsos vel refractorios MM renitentes vel unum saltem proteasome inhibitorem, unum medicamen immunomodulatorium, et unum anti-CD38 anticorpus in aperto pittacio, uno-bracchio, multi-centri inquisitioni inclusum est. assident efficacia. In dilectu aegroti convenerunt criteria quae a Myeloma Internationale Group Working (IMWG) pro morbo detecto proposita sunt.
Principales modi ut metirentur quam bene aliquid operatum esset responsionis obiectiva (ORR) et duratio responsionis (DOR), quae inventae sunt ab independens, obcaecatae centralis recensionis sequentes IMWG lineamenta. Nonaginta septem aegros, qui ante curationem BCMA directam numquam acceperant, sed quattuor saltem priores therapiae lineas habuerunt, proteasome inhibitorem, medicamentum immunomodulatorium, et anti-CD38 anticorpus monoclonale - primarium incolarum efficaciam effecit. Nonaginta septem aegri (95% CI: 47.3%, 67.7%) in commendatione dosis orr 57.7% habuerunt. Mediana DOR inter respondentes non perventum est post finem 11.1 mensium (95% CI: 12 menses non pervenerunt). 90.4% (95% CI: 78.4%, 95.9%) erat rate in sex mensibus, et 82.3% (95% CI: 67.1%, 90.9%) ad novem menses.
Elranatamab-bcmm’s prescribing information includes a Boxed Warning for neurologic damage, including immune effector cell-associated neurotoxicity (ICANS), and cytokine release syndrome (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, defatigatio, iniectio situs responsio, diarrhoea, tractus respiratorii superioris infectio, molestiae musculoskeletalis, pneumonia, appetitus decrescentes, praeceps, tussis, nausea, et pyrexia frequentissimi effectus latus (≥20%) erant. Decrescentia in haemoglobinis, neutrophillis, platelis, lymphocytis et albis cellulis sanguineis frequentissimae erant Gradus 3 ad 4 laboratorium abnormitates (≥20%).
Prima curatio dosis 76 mg in die 8 sequitur "gradus dosis 1" 12 mg in die 1 et "gradus dosis 2" of 32 mg in die 4. Dosages elranatamab-bcmm commendatae sunt. : 76 mg hebdomadis per Hebdomadam 24. Dosis intervallum debet mutare singulis duabus septimanis pro aegris, qui elranatamab-bcmm sumpserunt ad minus 24 septimanas, responsiones partiales vel melius ostenderunt, et responsiones sustinuerunt per duos saltem menses. Elranatamab-bcmm sumi potest, donec morbus ingravescat aut libra toxicitatis intolerabilis fiat.
