Agusta 2023: Pralsetinib (Gavreto, Genentech, Inc.) An ba da izini akai-akai ta Cibiyar Abinci da Magunguna don manya marasa lafiya tare da cutar kansar huhu na huhu (NSCLC), kamar yadda gwajin da FDA ta amince da shi.
Dangane da ƙimar amsawar gabaɗaya ta farko (ORR) da dorewar amsawa (DOR) a cikin marasa lafiya 114 da ke shiga cikin binciken ARROW (NCT03037385), multicenter, buɗaɗɗen lakabin, gwajin ƙungiyoyi da yawa, pralsetinib a baya an ba da izinin gaggawa ga NSCLC nuni a kan Satumba 4, 2020. Bisa ga bayanin daga 123 ƙarin marasa lafiya da ƙarin watanni 25 na biyo baya don auna tsawon lokacin amsawa, an yi canji zuwa amincewa na yau da kullum.
Jimillar marasa lafiya 237 tare da ci gaba na gida ko metastatic RET fusion-positive NSCLC sun nuna inganci. An bai wa marasa lafiya pralsetinib har sai cutar ta ci gaba ko kuma ba za a iya jurewa ba.
Kwamitin Bita Mai Zaman Kanta (BIRC) ya yanke shawarar cewa ORR da DOR sune mahimman matakan inganci. ORR shine 78% (95% CI: 68, 85) tsakanin marasa lafiya 107 waɗanda ba su taɓa samun magani ba, kuma DOR na tsakiya shine watanni 13.4 (95% CI: 9.4, 23.1). ORR ya kasance 63% (95% CI: 54, 71) tsakanin marasa lafiya 130 waɗanda suka riga sun sami maganin cutar sankara na platinum, kuma DOR na tsakiya shine watanni 38.8 (95% CI: 14.8, ba ƙima ba).
Rashin jin daɗi na tsoka, maƙarƙashiya, hauhawar jini, gudawa, gajiya, edema, pyrexia, da tari sune abubuwan da suka fi faruwa akai-akai (25%).
400 MG na pralsetinib ana sha da baki sau ɗaya a rana shine shawarar da aka ba da shawarar. Ana ba da shawarar shan pralsetinib akan komai a ciki (babu abinci aƙalla sa'o'i 2 kafin kuma aƙalla awa 1 bayan gudanar da pralsetinib).
