Nov 2023: I-Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) iyi-bispecific B-cell maturation antigen (BCMA)-eqondiswe ngama-CD3 T-cell engager eyanikezwa ukugunyazwa okusheshayo yi-Food and Drug Administration kubantu abadala abane-myeloma eminingi ebuyele emuva noma ephikisayo. okungenani ibe nemigqa yokwelapha emine yangaphambilini, ehlanganisa i-proteasome inhibitor, i-immunomodulatory agent, kanye ne-anti-CD38 monoclonal antibody.
Ku-MagnetisMM-3 (NCT04649359), iziguli ezine-MM ebuyele emuva noma ephikisayo ezimelana okungenani ne-proteasome inhibitor eyodwa, umuthi owodwa wokuvikela umzimba, kanye ne-anti-CD38 antibody eyodwa zifakwe kulebula evulekile, ingalo eyodwa, ucwaningo lwezikhungo eziningi ukuze hlola ukusebenza kahle. Lapho kubhaliswa, iziguli zahlangabezana nemibandela ebekwe yi-International Myeloma Working Group (IMWG) yezifo ezitholakalayo.
Izindlela eziyinhloko zokulinganisa ukuthi into ethile isebenze kahle kangakanani kwakuyizinga lokuphendula lenhloso (ORR) kanye nobude besikhathi sokuphendula (DOR), okutholwe ukubuyekezwa okuzimele, okuphuphuthekile okuphakathi okulandela imihlahlandlela ye-IMWG. Iziguli ezingamashumi ayisishiyagalolunye nesikhombisa ezazingakaze zithole ukwelashwa okuqondiswe yi-BCMA ngaphambili kodwa zaba nemigqa okungenani emine yokwelapha—i-proteasome inhibitor, isidakamizwa esivimbela ukuzivikela komzimba, kanye ne-anti-CD38 monoclonal antibody—yakha inani eliyinhloko elisebenza ngempumelelo. Iziguli ezingamashumi ayisishiyagalolunye nesikhombisa (95% CI: 47.3%, 67.7%) kumthamo onconyiwe zine-ORR engama-57.7%. I-DOR emaphakathi phakathi kwabaphenduli ayifinyelelwanga ngemva kokulandelwa kwezinyanga ze-11.1 (95% CI: izinyanga ezingu-12, azifinyelelwanga). I-90.4% (95% CI: 78.4%, 95.9%) yayiyizinga le-DOR ezinyangeni eziyisithupha, kanye nama-82.3% (95% CI: 67.1%, 90.9%) ezinyangeni eziyisishiyagalolunye.
Elranatamab-bcmm’s prescribing information includes a Boxed Warning for neurologic damage, including immune effector cell-associated neurotoxicity (ICANS), and i-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.
I-CRS, ukukhathala, impendulo yendawo yomjovo, isifo sohudo, ukutheleleka komgudu wokuphefumula ophezulu, ukungakhululeki kwemisipha namathambo, inyumoniya, ukuncipha kwesifiso sokudla, ukuqubuka, ukukhwehlela, isicanucanu, kanye ne-pyrexia kwakuyimiphumela emibi kakhulu (≥20%). Ukuncipha kwe- haemoglobin, ama-neutrophils, amaplatelet, ama-lymphocyte, namaseli egazi amhlophe kwakuyizinto ezingavamile kakhulu zaselabhorethri zeBanga lesi-3 ukuya kwelesi-4 (≥20%).
Umthamo wokuqala wokwelapha we-76 mg ngosuku lwe-8 ulandelwa "umthamo wesinyathelo-up 1" we-12 mg ngosuku 1 kanye "nomthamo we-step-up 2" we-32 mg ngosuku lwe-4. Izilinganiso ezinconyiwe ze-elranatamab-bcmm zimi kanje. : 76 mg masonto onke ngeviki 24. Isikhathi somthamo kufanele sishintshe sibe njalo emavikini amabili ezigulini ezithathe i-elranatamab-bcmm okungenani amaviki angu-24, zabonisa izimpendulo eziyingxenye, noma ezingcono, nezimpendulo eziqhubekayo okungenani izinyanga ezimbili. I-Elranatamab-bcmm ingase ithathwe kuze kube yilapho isifo siba sibi kakhulu noma izinga lobuthi lingabekezeleleki.
