August 2023: Talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) yakapihwa kukurumidza kubvumidzwa neChikafu neDrug Administration kurapwa kwevakuru vane kudzokazve kana refractory akawanda myeloma avo vakambopfuura mana mitsara yekurapa, kusanganisira proteasome inhibitor, immunomodulatory. mushonga, uye anti-CD38 monoclonal antibody.
A single-arm, open-label, multicenter research inonzi MMY1001 (MonumentTAL-1) (NCT03399799, NCT4634552) iyo yaisanganisira varwere ve187 vakambove neine kanenge mana systemic mishonga yakaongorora kushanda kwekurapa. Kutevera madosi maviri ekukwira muvhiki yekutanga yekurapa, varwere vakagamuchira talquetamab-tgvs 0.4 mg/kg subcutaneously vhiki nevhiki kana talquetamab-tgvs 0.8 mg/kg subcutaneously biweekly (masvondo maviri ega ega), vachitevera matanho matatu-up-up, kusvikira chirwere chakura. kana huturu husingashiviriri.
Kuwanda kwehuwandu hwekupindura (ORR) uye nguva yekupindura (DOR), iyo yakaongororwa nekomiti yakazvimirira yekuongorora yakavakirwa pamirayiridzo yeIMWG, ndiyo yaive yekutanga efficacy mhedzisiro matanho. Varwere vaimbove neine mitsara mina yekurapa, senge proteasome inhibitor, immunomodulator, uye anti-CD38 monoclonal antibody, yakagadzira iyo yekutanga kushanda zvakanaka. DOR yepakati yaiva mwedzi 9.5 (95% CI: 6.5, isingaenzaniswi) uye ORR muvarwere ve100 vanotora 0.4 mg / kg vhiki nevhiki yaiva 73% (95% nguva yekuvimba (CI): 63.2%, 81.4%). Iyo yepakati DOR muvarwere makumi masere nevanomwe vanotora 87 mg/kg biweekly haina kufungidzirwa, nepo ORR yaive 0.8% (73.6% CI: 95%, 63%). Vanosvika 82.4% yevakabvunzwa vanonzi vakaramba vachipindura kweinenge mwedzi mipfumbamwe.
A Boxed Warning for immunological effector cell-associated neurotoxicity (ICANS) and neurologic toxicity, including life-threatening or lethal cytokine release syndrome (CRS), is included in the prescribing material for talquetamab-tgvs. Talquetamab-tgvs is only offered in a restricted programme under a Risk Evaluation and Mitigation Strategy (REMS), known as the Tecvayli-Talvey REMS, due to the risks of CRS and neurologic toxicity, including ICANS.
Varwere mazana matatu nemakumi matatu nevapfumbamwe muhuwandu hwekuchengetedza vakawana CRS, dysgeusia, kusagadzikana kwembambo, kusagadzikana kwemusculoskeletal, kuputika kweganda, kupera simba, kupera uremu, muromo wakaoma, pyrexia, xerosis, dysphagia, hutachiona hwepamusoro hwekufema, manyoka, uye zviitiko zvakashata mune izvozvo. odha (339%).
Talquetamab-tgvs inofanira kupihwa pamwero we0.4 mg/kg pasvondo kana 0.8 mg/kg biweekly. Iyo yakazara dosi marongero akanyorwa mune yekuraira ruzivo.
