Hukumar Abinci da Magunguna ta ba da izini repotrectinib (Augtyro, Kamfanin Bristol-Myers Squibb) don ci gaba na gida ko metastatic ROS1-tabbataccen ciwon huhu mara ƙananan ƙwayoyin cuta (NSCLC) akan Nuwamba 15, 2023.
Wannan amincewar FDA shine farkon wanda ya ƙunshi marasa lafiya tare da ROS1-tabbatacce NSCLC waɗanda aka riga aka bi da su tare da ROS1 tyrosine kinase inhibitor (TKI), da kuma mutanen da ba su da maganin TKI a baya.
An ba da izinin bin gwajin asibiti na TRIDENT-1 (NCT03093116), nazarin duniya wanda ya haɗa da cibiyoyi da yawa, tare da hannu guda ɗaya, ƙirar buɗaɗɗen lakabin, da ƙungiyoyin haƙuri daban-daban tare da ROS1-tabbatacce a cikin gida ko NSCLC metastatic. An kimanta tasiri a cikin marasa lafiya na 71 ROS1 TKI-naïve waɗanda suka sami matsakaicin layin 1 na baya na chemotherapy na tushen platinum da / ko immunotherapy, kuma a cikin marasa lafiya 56 waɗanda suka karɓi 1 ROS1 TKI na baya ba tare da chemotherapy na tushen platinum ba ko rigakafi.
Matakan inganci na farko sune ƙimar amsawa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR) dangane da RECIST v1.1 kamar yadda aka kimanta ta hanyar bita ta tsakiya mara son kai. Tabbatar da Maƙasudin Amsa Maƙasudin (ORR) shine 79% (95% CI: 68, 88) a cikin rukunin marasa lafiya waɗanda ba su da magani tare da ROS1 TKI a baya, da 38% (95% CI: 25, 52) a cikin marasa lafiya waɗanda an riga an karɓi magani tare da mai hana ROS1. Matsakaicin lokacin amsawa shine watanni 34.1 (95% CI: 25.6, ba mai ƙima ba) da watanni 14.8 (95% CI: 7.6, ba ƙima ba) a cikin ƙungiyoyin biyu, bi da bi. An yi la'akari a cikin raunuka na kwakwalwa na marasa lafiya tare da ƙananan ƙwayoyin cuta na tsakiya na tsakiya, da kuma a cikin mutane masu juriya na juriya bayan tyrosine kinase inhibitor far.
Mafi yawan martani mara kyau, wanda ke faruwa a cikin fiye da 20% na lokuta, sun kasance dizziness, dysgeusia, neuropathy na gefe, maƙarƙashiya, dyspnea, ataxia, gajiya, matsalolin fahimta, da raunin tsoka.
Shawarar da aka ba da shawarar repotrectinib shine 160 MG ana sha baki ɗaya sau ɗaya a rana, tare da ko ba tare da abinci ba, na kwanaki 14. Bayan haka, ya kamata a ƙara adadin zuwa 160 MG sau biyu a rana har sai cutar ta ci gaba ko rashin haƙuri.
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
