Agusta 2021: Bayan gazawar aƙalla layuka biyu na farfajiyar tsarin, Hukumar Abinci da Magunguna ta amince belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), mai hanawa na kinase, ga tsofaffi da marasa lafiya na yara masu shekaru 12 da haihuwa tare da cutar ta-da-mai-cuta (GVHD na kullum).
KD025-213 (NCT03640481), bazuwar, labule, gwajin gwaji iri-iri wanda aka kula da marasa lafiya 65 tare da GVHD na yau da kullun tare da belumosudil 200 MG da aka gudanar da baki sau ɗaya a rana, an yi amfani da su don tantance inganci.
Matsakaicin adadin amsa gabaɗaya (ORR) ta hanyar Zagayowar 7 Day 1 shine ma'aunin ƙarshen inganci na farko, tare da cikakkiyar amsa da aka ayyana azaman cikakkiyar amsa (CR) ko amsa juzu'i (PR) bisa ga 2014 NIH Consensus Development Project akan gwaji na asibiti a cikin Chronic Graft jagororin Cuta-da-Mai watsa shiri. ORR ya kasance 75% (95 bisa dari CI: 63, 85); 6% na marasa lafiya sun sami cikakkiyar amsa, kuma kashi 69 cikin 1.8 suna da wani bangare na amsawa. Matsakaicin lokacin da aka ɗauka don samun amsar farko shine watanni 95 (1.0 bisa dari CI: 1.9, 1.9). Matsakaicin matsakaicin lokacin amsawa don GVHD na yau da kullun shine watanni 95, wanda aka auna daga amsawar farko ta hanyar ci gaba, mutuwa, ko sabbin hanyoyin jiyya (1.2 bisa dari CI: 2.9, 62). Babu mace-mace ko sabon tsarin magani na tsarin da ya faru a cikin kashi 95 (46 bisa dari CI: 74, 12) na marasa lafiya waɗanda suka sami amsa don akalla watanni XNUMX bayan amsawa.
Cututtuka, asthenia, tashin zuciya, gudawa, dyspnea, tari, edoema, zubar jini, ciwon ciki, ciwon musculoskeletal, ciwon kai, phosphate ya ragu, gamma glutamyl transferase ya ƙaru, ƙwayoyin lymphocytes sun ragu, kuma hauhawar jini sune mafi yawan halayen rashin lafiyan (20%), gami da dakin gwaje -gwaje rashin daidaituwa.
Belumosudil yakamata a sha sau ɗaya a rana, tare da abinci, a cikin adadin 200 MG.
