FDA ta amince eflornithine (IWILFIN, USWM, LLC) a ranar 13 ga Disamba, 2023, don rage haɗarin sake dawowa a cikin manya da yara masu haɗari neuroblastoma (HRNB) waɗanda ke da martani ga ɓangarori na baya-bayan nan, maganin multimodality, kamar anti-GD2 immunotherapy.
Wannan alama ce farkon amincewar FDA na wani magani da aka tsara don rage yuwuwar sake dawowa a cikin yara marasa lafiya tare da HRNB.
An yi la'akari da tasiri a cikin gwajin da aka kwatanta da sakamakon daga Nazarin 3b (ƙungiyar gwaji) tare da Nazarin ANBL0032 (ƙungiyar kula da waje da aka samar daga gwaji na asibiti). Nazari 3b (NCT02395666) gwaji ne na tsakiya da yawa wanda buɗaɗɗen lakabin da ba a kayyade ba, wanda ya ƙunshi ƙungiyoyi biyu. Marasa lafiya 105 da suka cancanta tare da babban haɗari neuroblastoma daga rukuni ɗaya (Stratum 1) an ba da eflornithine a baki, sau biyu a kowace rana a cikin adadin da aka ƙayyade ta wurin yanayin jiki (BSA) har sai cutar ta ci gaba, rashin yarda da guba, ko tsawon shekaru 2. An tsara nazarin 3b a gaba don kwatanta sakamako tare da ƙimar rayuwa kyauta ta tarihi (EFS) daga Nazarin ANBL0032 kamar yadda aka ruwaito a cikin wallafe-wallafen da aka buga.
Nazarin ANBL0032 ya kasance cibiyar da yawa, alamar buɗewa, gwajin bazuwar da aka kwatanta da dinutuximab, granulocyte-macrophage colony-stimulating factor, interleukin-2, da cis-retinoic acid zuwa cis-retinoic acid kadai a cikin marasa lafiya na yara tare da babban haɗari neuroblastoma. Hannun kula da waje ya dogara ne akan bayanai daga marasa lafiya 1,241 a cikin gwajin gwaji.
Marasa lafiya waɗanda suka cika ma'auni don kwatanta tsakanin Nazarin 3b da ANBL0032 kuma suna da cikakkun bayanai don wasu covariates na asibiti an haɗa su a cikin rabo na 3: 1 dangane da ƙimar su. Binciken farko ya haɗa da marasa lafiya 90 da aka bi da su tare da IWILFIN da 270 masu kula da marasa lafiya daga Nazarin ANBL0032.
Ma'aunin inganci na farko shine tsira ba tare da aukuwa ba (EFS), wanda ya ƙunshi ci gaban cuta, sake dawowa, rashin lafiya na biyu, ko mutuwa daga kowane dalili. Wani ma'aunin inganci shine gaba ɗaya rayuwa (OS), wanda aka ayyana azaman mutuwa daga kowane dalili. Matsakaicin haɗarin EFS (HR) a cikin bincike na farko shine 0.48 tare da tazarar amincewar 95% (CI) na 0.27 zuwa 0.85. OS HR ya kasance 0.32 tare da 95% CI na 0.15 zuwa 0.70. Saboda rashin tabbas a cikin ƙididdige tasirin magani wanda ya zo tare da ƙirar bincike mai sarrafawa na waje, an yi ƙarin nazari akan ƙananan jama'a ko amfani da hanyoyin ƙididdiga daban-daban. EFS HR ya bambanta tsakanin 0.43 (95% CI: 0.23, 0.79) da 0.59 (95% CI: 0.28, 1.27), yayin da OS HR ya fito daga 0.29 (95% CI: 0.11, 0.72) zuwa 0.45 (95%) 0.21, 0.98).
A cikin binciken 3b, illolin da aka fi sani da (≥5%), wanda kuma ya haɗa da rashin daidaituwa na lab, sun haɗa da hanci, gudawa, tari, sinusitis, ciwon huhu, kamuwa da cutar numfashi na sama, conjunctivitis, amai, zazzabi, rashin lafiyar rhinitis, ƙananan neutrophils, mafi girma ALT da AST, asarar ji, kamuwa da fata, da kamuwa da cutar urinary.
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
