Hukumar Abinci da Magunguna ta ba da izini da sauri ga pirtobrutinib (Jaypirca, Eli Lilly da Kamfani) a ranar 1 ga Disamba, 2023, ga manya masu fama da cutar sankarar lymphocytic na yau da kullun ko ƙananan lymphoma na lymphocytic (CLL/SLL) waɗanda suka sha aƙalla layi biyu na farko na far. ciki har da mai hana BTK da mai hana BCL-2.
Binciken ya duba yadda ya yi aiki sosai a cikin BRUIN (NCT03740529), alamar duniya, buɗaɗɗen lakabi, hannu ɗaya, gwajin multicohort tare da mutanen 108 waɗanda ke da CLL ko SLL kuma sun riga sun sami akalla wasu jiyya guda biyu, ciki har da mai hana BTK da kuma mai hanawa BCL-2. Marasa lafiya sun shiga tsaka-tsaki na layin 5 na baya, tare da kewayon 2 zuwa 11. Kashi saba'in da bakwai na marasa lafiya sun daina amfani da mai hana BTK na baya saboda rashin ƙarfi ko rashin lafiya. An ba da miyagun ƙwayoyi Pirtobrutinib a baki a kashi na 200 MG sau ɗaya a rana kuma ana kiyaye shi har sai cutar ta ci gaba ko rashin yarda da guba ya faru.
Ma'auni na inganci na farko shine ƙimar amsawa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), wanda kwamitin nazari mai zaman kansa ya kimanta bisa ka'idojin 2018 iwCLL. Matsakaicin martani na haƙiƙa (ORR) shine 72% tare da tazarar amincewa ta 95% (CI) na 63% zuwa 80%, kuma tsawon lokacin amsawa (DOR) shine watanni 12.2 tare da 95% CI na 9.3 zuwa 14.7. Duk amsoshin ba su cika ba.
Mafi yawan sakamako masu illa (≥ 20%), ba tare da sharuɗɗan da suka shafi dakin gwaje-gwaje ba, sune gajiya, rauni, tari, rashin jin daɗi na musculoskeletal, COVID-19, gudawa, ciwon huhu, ciwon ciki, dyspnea, zubar jini, edema, tashin zuciya, pyrexia, da ciwon kai. Halin rashin daidaituwa na digiri na 3 ko 4 da ke shafar fiye da 10% na marasa lafiya sun haɗa da rage adadin neutrophils, anemia, da raguwar adadin platelet. 32% na marasa lafiya sun sami cututtuka masu tsanani, tare da cututtuka masu mutuwa a cikin 10% na lokuta. Abubuwan da aka ba da magani sun haɗa da gargaɗi da shawarwari don cututtuka, zubar jini, cytopenias, arrhythmias na zuciya, da kuma ciwon daji na farko na gaba.
Matsakaicin adadin pirtobrutinib da aka ba da shawarar shine 200 MG ana sha baki ɗaya sau ɗaya a rana har sai cutar ta ci gaba ko tasirin da ba za a iya jurewa ba.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
