Nov 2023: Elranatamab-bcmm (Elrexfio, Pfizer, Inc.) is bispecific B-cell maturation antigen (BCMA)-inotungamirwa CD3 T-cell engager iyo yakapihwa yakakurumidza kubvumidzwa neChikafu uye Drug Administration kune vakuru vane kudzoka kana kuramba akawanda myeloma vane yakanga ine mitsetse mina isati yasvika yekurapa, iyo yaisanganisira proteasome inhibitor, an immunomodulatory agent, uye anti-CD38 monoclonal antibody.
MuMagnetisMM-3 (NCT04649359), varwere vane MM yakadzokororwa kana kuti refractory inoramba kune imwechete proteasome inhibitor, imwe immunomodulatory mushonga, uye imwe anti-CD38 antibody yakaverengerwa muakavhurika-label, single-ruoko, akawanda-center research to. kuongorora kushanda. Pakunyoresa, varwere vakasangana nemaitiro akatarwa neInternational Myeloma Working Group (IMWG) yechirwere chinoonekwa.
Nzira huru dzekuyera kuti chimwe chinhu chakashanda sei chaive chinangwa chekupindura (ORR) uye nguva yekupindura (DOR), iyo yakawanikwa neyakazvimiririra, yakapofumadzwa yepakati wongororo ichitevera IMWG nhungamiro. Varwere makumi mapfumbamwe nevanomwe vakanga vasati vambowana BCMA-directed therapy asi vaine mitsetse mina yerapiro isati yasvika-proteasome inhibitor, immunomodulatory drug, uye anti-CD38 monoclonal antibody-yakaita iyo yekutanga kushanda zvakanaka kwevanhu. Varwere makumi mapfumbamwe nevanomwe (95% CI: 47.3%, 67.7%) pamutengo wakakurudzirwa waiva neORR ye57.7%. DOR yepakati pakati pevapinduri haina kusvika mushure mekutevera kwemwedzi ye11.1 (95% CI: mwedzi ye12, isina kusvika). 90.4% (95% CI: 78.4%, 95.9%) yaiva DOR chiyero mumwedzi mitanhatu, uye 82.3% (95% CI: 67.1%, 90.9%) mumwedzi mipfumbamwe.
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, kuneta, mhinduro yejekiseni, manyoka, hutachiona hwepamusoro hwekufema, kusagadzikana kwemusculoskeletal, mabayo, kuderera kwechido, mapundu, kukosora, kusvotwa, uye pyrexia ndizvo zvaiwanzo konzeresa (≥20%). Kuderera kwehemoglobin, neutrophils, maplatelet, lymphocytes, uye masero machena eropa ndiwo aiwanzoitika Giredhi 3 kusvika 4 rabhoritari abnormalities (≥20%).
Nhamba yekutanga yekurapa ye76 mg paZuva 8 inoteverwa ne "nhanho-up dose 1" ye12 mg paZuva 1 uye "danho-up dose 2" ye 32 mg paZuva 4. Iyo yakakurudzirwa elranatamab-bcmm dosages ndeyotevera. : 76 mg vhiki nevhiki kuburikidza neSvondo 24. Nguva yekutora inofanira kuchinja kune mavhiki maviri ega ega kune varwere vakatora elranatamab-bcmm kwemavhiki mashoma 24, vakaratidza mhinduro dzisina kukwana, kana kuti zviri nani, uye mhinduro dzakagadziriswa kwemwedzi miviri. Elranatamab-bcmm inogona kutorwa kusvika chirwere chawedzera kana mwero wechepfu usisagoneke.
