July 2022: Crizotinib (Xalkori, Pfizer Inc.) yakapiwa mvumo neChikafu neDrug Administration (FDA) yekurapa kwevakuru nevana varwere vane makore 1 uye vakuru vakaonekwa kuti vane unrectable, kudzokorora, kana refractory inflammatory anaplastic lymphoma kinase (ALK). ) -positive myofibroblastic tumors yaive yakanaka kune ALK (IMT).
Zvose kuchengetedzwa uye kushanda kwe crizotinib zvakaongororwa muzvikamu zviviri zvakasiyana-siyana, ruoko-rumwechete, muedzo wakazaruka. Miedzo iyi yaisanganisira vese vana uye varwere vakuru vane isingarambiki, inodzokororwa, kana yekuramba ALK-positive IMT. Varwere vevana vakapinda muyedzo ADVL0912 (NCT00939770), nepo varwere vakuru vakapinda muyedzo A8081013 (NCT01121588).
Chiyero chekupindura kwechinangwa chaive chiratidzo chekutanga chekushanda chakayerwa mumiedzo iyi (ORR). Mhinduro yechinangwa yakawanikwa mu12 kubva kune 14 varwere vevana (iyo inofananidzwa ne86% kubudirira kwehuwandu ne95% nguva yekuvimba kubva ku57% kusvika ku98%) apo varwere vakaongororwa nekomiti yakazvimirira yekuongorora. Vashanu kubva kune vanomwe varwere vakura vakaratidza zvinangwa zvekuvandudza.
Zviratidzo zvekurutsa, kusvotwa, manyoka, kurwadziwa mudumbu, kuputika, kukanganiswa kwekuona, chirwere chepamusoro chekufema, kukosora, pyrexia, kurwadziwa kwemusculoskeletal, kuneta, edoema, uye kuvimbiswa ndiyo yakajairika maitiro asina kunaka (35 muzana) muvarwere vevana. Muvarwere vakuru, kusawirirana kwekuona, kusvotwa, uye edoema ndiko kwakava kukanganisa kwakaitika kakawanda kupfuura makumi matatu neshanu muzana yenguva.
Crizotinib inofanira kupiwa nemuromo kaviri pazuva pachiyero che 250 milligrammes (mg) muvarwere vakura kusvikira chirwere chacho chawedzera kana kuti huturu husingagamuchirwi hunosvika. Nomuromo kutungamirira 280 mg / m2 kaviri zuva nezuva ndiyo dhigirii yevana inokurudzirwa kusvikira kufambira mberi kwechirwere kana kutyisa kusingagamuchirwi kuchiitika.
View full prescribing information for Xalkori.
