Kukadzi 2023: Mvumo yekukurumidza inopihwa neFDA kune pirtobrutinib (Jaypirca, Eli Lilly uye Kambani) yekudzokazve kana refractory mantle cell lymphoma.
MuBRUIN (NCT03740529), yakavhurika-label, multicenter, imwe-ruoko ruyedzo rwepirtobrutinib monotherapy iyo yaisanganisira 120 MCL varwere vakambogamuchira BTK inhibitor kurapwa, kushanda kwakaongororwa. Varwere vakanga vagamuchira pakati pemitsara mitatu yekurapa kare, ne93% vachiwana maviri kana kupfuura. Ibrutinib (67%), acalabrutinib (30%), uye zanubrutinib (8%), iyo yainyanya kunyorwa kare BTK inhibitors, yakamiswa ne83% yevarwere nekuda kwechirwere chinoramba kana kuwedzera. Pirtobrutinib yakapiwa nemuromo kamwe chete pazuva pachiyero che 200 mg uye yakaenderera mberi kusvikira chirwere ichi chichienderera mberi kana kuti migumisiro yakave isingagoneki.
Huwandu hwekupindura kwese (ORR) uye nguva yekupindura (DOR), sekutsanangurwa nekomiti yakazvimirira yekuongorora uchishandisa nzira yeLugano, yaive yekutanga matanho ekubudirira. ORR yaive 50% (95% CI: 41, 59) uye 13% yevakapindura vakapedza ongororo yakazara. Iyo inofungidzirwa DOR mwero pamwedzi mitanhatu yakafungidzirwa kuva 6% (65.3% CI: 95, 49.8), uye inofungidzirwa yepakati DOR yaive mwedzi 77.1 (8.3% CI: 95, NE).
Muvarwere vane MCL, kuneta, kusagadzikana kwemasculoskeletal, diarrhoea, edoema, dyspnea, mabayo, uye maronda ndizvo zvaiwanzoita mhedzisiro (15%). Kuderera kweneutrophil, lymphocyte, uye maplatelet kuverenga kwaiva giredhi 3 kana 4 kusaenzana kwerabhoritari mu10% yevanhu. Kuchenjerera uye nyevero pamusoro pezvirwere, kubuda ropa, cytopenias, atrial fibrillation uye flutter, uye chechipiri chechirwere chikuru chinosanganiswa mune zvinyorwa.
Inorayirwa kutora 200 mg yepirtobrutinib kamwe chete zuva rega rega kusvikira chirwere ichi chichienderera mberi kana kuti chepfu inosagadzikana.
