November 2022: Pemigatinib (Pemazyre, Incyte Corporation) yakapihwa rezinesi neFood and Drug Administration kuti ishandiswe kune vanhu vane relapsed kana refractory myeloid/lymphoid neoplasms (MLNs) ine yakashandurwa fibroblast growth factor receptor 1 (FGFR1).
FIGHT-203 (NCT03011372), multicenter open-label, single-arm trial nevarwere ve28 vakange vadzokera shure kana kuti refractory MLNs neFGFR1 rearrangement, yakaongororwa kushanda. Varwere vaisangana nemaitiro ekukodzera vangave vasingakodzeri kana kuti vaive vadzokera shure zvichitevera allogeneic hematopoietic stem cell transplantation (allo-HSCT) kana kurapwa-kugadzirisa chirwere (semuenzaniso, chemotherapy). Pemigatinib yakapihwa kusvikira chirwere ichi chakura, chepfu yakava isingagoneki, kana varwere vaigona kugamuchira allo-HSCT.
Kusarudzwa kwevanhu uye maitiro ekutanga aisanganisira zvinotevera: 64% vakadzi; 68% chena; 3.6% yevatema kana yeAfrica America; 11% vokuAsia; 3.6% American Indian/Alaska Native; uye 88% ECOG maitiro ekuita kwe0 kana 1. Nguva yepakati yaiva 65 makore (range, 39 kusvika 78); 3.6% yevatema kana yeAfrica America; 68% chena; uye 68% machena.
Kubva pamhinduro yakakwana (CR) mazinga akasangana nemaitiro ekupindura akananga kune rudzi rwechirwere che morphologic, kushanda kwakatemwa. 14 kubva kune 18 varwere vane extramedullary chirwere (EMD) uye chisingaperi chikamu mumwongo (78%; 95% CI: 52, 94) vakawana kuregererwa kwakakwana (CR). Avhareji yenhamba yemazuva kuCR yaive 104. (range, 44 kusvika 435). Nguva yepakati (kubva pa1+ kusvika 988+ mazuva) haina kuwanikwa. Vaviri vevarwere vana vaive nechikamu chekuputika mumwongo vaine kana vasina EMD (nguva: 1+ uye 94 mazuva) vaive mukuregererwa. Mumwe wevatatu varwere vaive neEMD voga vakawana CR (inogara 64+ mazuva). Iyo yakazara cytogenetic response rate yevarwere vose ve28-kusanganisira 3 pasina morphologic chirwere-yaiva 79% (22/28; 95% CI: 59, 92).
Hyperphosphatemia, chipikiri chepfu, alopecia, stomatitis, manyoka, ziso rakaoma, kuneta, kuputika, kupererwa neropa, kuvimbiswa, muromo wakaoma, epistaxis, serous retinal detachment, kurwadziwa kwekupedzisira, kuderera kwechido, ganda rakaoma, dyspepsia, kurwadziwa shure, kusvotwa, kusaona, peripheral edoema, uye dzungu ndizvo zvaiwanzoitika (20%) maitiro asina kunaka aionekwa nevarwere.
Yakaderedzwa phosphate, yakaderedzwa lymphocytes, yakaderedzwa leukocytes, yakaderedzwa maplatelet, yakakwira alanine aminotransferase, uye yakaderedzwa neutrophils ndiyo yainyanya kupararira yeGrade 3 kana 4 laboratory abnormalities (10%).
Inorayirwa kutora 13.5 mg ye pemigatinib kamwe chete zuva nezuva kusvikira chirwere ichi chichienderera mberi kana kuti kune huturu husingaregi.
View full prescribing information for Pemazyre.
