Iulii 2023: Cibus et medicamentum medicamentum acceleravit approbationem epcoritamab-bysp (Epkinly, Genmab US, Inc.) pro relapso vel refractorio diffusione magna lymphoma B-cell (DLBCL) non aliter determinata, inclusa DLBCL quae ab lymphoma inertia venit et gradus summus. Lymphoma B-cellula post duas vel plures lineas therapiae systemicae.
Epcoritamab-bysp, bispecificus CD20-directus CD3 T-cellulator pugnator, probatus est in EPCORE NHL-1 (NCT03625037), titulus apertus, cohortis multicentis, multicentis, unius brachii studium cum aegris relapso vel refractorio B-cell. lymphoma. Efficacia hominum facta est ex aegris relapsis vel refractoribus DLBCL, non aliter determinatis, incluso DLBCL ab lymphoma inerti lymphoma et gradu B-cellularum, post duas vel plures lineas therapiae systemicae, quarum saltem una anti CD148 monoclonali. antibody-quae justo.
Committee Independentis Review usus Lugano 2014 criteria ad modum responsionis altiore (ORR) instare, quae mensura efficaciae erat clavis. ORR erat 61% (95% CI: 53-69), et 38% aegrorum integram reactionem habuit. Cum mediana consecutione 9.8 mensium respondentium, mediana periodus responsionis (DOR) projecta fuit 15.6 mensium (95%CI: 9.7, non attigit).
The prescription information has a Boxed Warning about 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 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 solum dari debet ab operario medico medico cum iure medicinae auxilio ut graves reactiones agere sicut CRS et ICANS. Propter casum CRS et ICANS, homines qui 48 mg ad 15 diem cycli capiunt 1 in valetudinarium 24 horis manere debent.
Effectus laterales, qui frequentissime acciderant (circiter 20%), erant CRS, languor, dolor in musculis et articulis, motus in injectione situs, febris, dolor abdominis, nausea et diarrhoea. Frequentissima Gradus 3 ad 4 lab abnormitates (10%) erant numerus inferiorum lymphocytarum, neutrophili, cellae sanguineae albae, haemoglobinae et lamellae.
Consilium curationis suggessit epcoritamab-bysp equini singulis diebus XXVIII dare, donec morbus ingravescat aut latus effectus nimium mali sint. In Cycle 28, dosis suggesta est 1 mg in diem 0.16, 1 mg in diem 0.80, et 8 mg in diebus 48 et 15. Hoc sequitur certum dosis 22 mg quavis hebdomadis pro Cyclis 48 per 2, singulis hebdomadibus. pro Cycles 3 per 4, et deinde per quatuor septimanas per cyclos sequentes per diem I.
View full prescribing information for Epkinly.
