Sept 2022: Ibrutinib (Imbruvica, Pharmacyclics LLC) yakagamuchirwa neFood and Drug Administration kuti ishandiswe muvarwere vevana vane chirwere chisingaperi chinopesana nechirwere chechirwere (cGVHD) avo vari vaduku kune 1 gore uye vakakundikana imwe kana kupfuura mutsara we systemic therapy. Mushonga wemuromo, mapiritsi, uye makapisi mienzaniso yekuumbwa.
Ibrutinib's efficacy yakaongororwa mu iMAGINE (NCT03790332), yakazaruka-label, multi-center, single-arm test yevana uye vechidiki vane mwero kana yakaoma cGVHD. Vatori vechikamu vakasiyana muzera kubva pa1 gore kusvika pasi pemakore makumi maviri nemaviri. Varwere ve22 vaida kurapwa kwakawedzerwa mushure mekunge imwe kana mimwe mitsara yemishonga ye systemic yakundikana uye vakanyoreswa mukuedzwa. Kana genitourinary kubatanidzwa mune imwe nhengo ndiyo chete chiratidzo cheCGVHD, varwere vakanga vasingabatanidzwi.
Avhareji yezera remurwere yaive makore gumi nematatu (renji, 13 kusvika 1). Zvinotevera ndezvimwe zvehuwandu hwevarwere makumi mana nevanomwe: 19% yevagari vemo varume, 47% vachena, 70% vatema kana veAfrica America, uye 36% haina kutaurwa.
Yese yekupindura mwero (ORR) kuburikidza neVhiki 25 yakashanda seyakanyanya kushanda mhedzisiro chiratidzo. Zvinoenderana neiyo 2014 NIH Consensus Development Project Response Criteria, ORR inosanganisira yakazara kana chidimbu mhinduro. Pakazosvika Svondo 25, ORR yakanga yasvika 60% (95% CI: 44, 74). Avhareji yenguva yaitora kuti mhinduro ipiwe yaive mwedzi 5.3 (95% CI: 2.8, 8.8). Iyo yepakati nguva yeCGVHD yaive mwedzi ye14.8 (95% CI: 4.6, isingaongororwe) kubva pakupindura kwekutanga kurufu kana kutsva systemic kurapwa.
Anemia, marwadzo emusculoskeletal, pyrexia, manyoka, mabayo, marwadzo emudumbu, stomatitis, thrombocytopenia, uye kutemwa nemusoro ndizvo zvaiwanzoitika zviitiko zvakaipa (20%), sezvakaita pyrexia, manyoka, mabayo, kurwadziwa mudumbu, uye stomatitis.
Nhamba yakakurudzirwa ye IMBRUVICA ndeye 420 mg muromo kamwe chete zuva nezuva kune varwere vane makore gumi nemaviri uye vakuru vane cGVHD uye 12 mg / m240 muromo kamwe chete zuva nezuva (kusvika pachiyero che 2 mg) kune varwere 420 kusvika pasi pemakore gumi nemaviri vane cGVHD. , kusvika cGVHD yafambira mberi, kudzoka kwechirwere chepasi, kana chepfu isingagamuchirwi.
Wona ruzivo rwakazara rwekurayira Imbruvica.
