FDA ta ba da izinin enzalutamide don maganin ciwon daji na prostate wanda ba na metastatic ba.
Hukumar Abinci da Magunguna ta amince da enzalutamide (Xtandi, Astellas Pharma US, Inc.) don ciwon daji na prostate wanda ba na metastatic ba (nmCSPC) tare da maimaita biochemical a babban haɗarin metastasis (babban haɗarin BCR) akan Nuwamba 16, 2023.
An kimanta tasiri a cikin EMBARK (NCT02319837), bazuwar, nazarin asibiti mai sarrafawa wanda ya shafi marasa lafiya 1068 tare da ciwon gurguwar ƙwayar cuta wanda ba na metastatic ba da ciwon gurguwar ƙwayar cuta da kuma sake dawowar ƙwayoyin cuta mai haɗari. Duk marasa lafiya sun sha maganin prostatectomy mai tsattsauran ra'ayi da / ko radiation tare da niyyar warkewa a baya, suna da lokacin PSA sau biyu na watanni 9 ko ƙasa da haka, kuma ba su cancanci samun ceton rediyo lokacin da suka shiga binciken ba. An ba da izini ga mahalarta a cikin rabo na 1: 1: 1 don karɓar ko dai enzalutamide 160 MG sau ɗaya kowace rana tare da leuprolide a cikin makanta, enzalutamide 160 MG sau ɗaya kowace rana a matsayin wakili guda ɗaya a cikin alamar alama, ko placebo mai makanta sau ɗaya kowace rana. tare da leuprolide.
Sakamakon farko da aka yi nazari a cikin binciken shine rayuwa marar amfani (MFS), wanda aka yi la'akari da shi ta hanyar nazari na tsakiya mai ban sha'awa, kwatanta enzalutamide tare da leuprolide zuwa placebo da leuprolide. Ƙarin ingantattun matakan sakamako sune rayuwa marar gazawa (MFS) don enzalutamide monotherapy idan aka kwatanta da placebo + leuprolide da rayuwa gaba ɗaya (OS).
Enzalutamide da leuprolide sun nuna ingantaccen ci gaba na ƙididdiga a cikin rayuwa marar lafiya idan aka kwatanta da placebo da leuprolide, tare da haɗarin haɗari na 0.42 da p-darajar ƙasa da 0.0001. Enzalutamide monotherapy ya nuna haɓakar ƙididdiga mai mahimmanci a cikin rayuwa ba tare da metastasis ba idan aka kwatanta da placebo da leuprolide, tare da haɗarin haɗari na 0.63 (95% CI: 0.46, 0.87; p-darajar = 0.0049). A lokacin nazarin MFS, bayanan OS ba su cika ba, suna nuna adadin mace-mace 12% a cikin jimillar yawan jama'a.
Abubuwan illa na yau da kullun (≥ 20% abin da ya faru) a cikin mutanen da aka yi musu magani tare da enzalutamide a hade tare da leuprolide sune zafi mai zafi, ciwon tsoka, gajiya, faɗuwa, da zub da jini. Sakamakon gama gari na enzalutamide monotherapy sun haɗa da gajiya, gynecomastia, ciwon musculoskeletal, taushin nono, ruwan zafi, da zub da jini.
Matsakaicin adadin enzalutamide da aka ba da shawarar shine MG 160 ana sha da baki sau ɗaya a rana, tare da ko ba tare da abinci ba, har sai ci gaban rashin lafiya ko guba mara yarda. Ana iya ba da Enzalutamide tare da ko ba tare da analog na GnRH ba. Ana iya dakatar da maganin Enzalutamide idan matakan PSA sun kasa 0.2 ng/mL bayan makonni 36 na jiyya. Za a iya sake farawa da jiyya lokacin da matakan PSA suka kai> 2.0 ng/mL ga mutanen da suka sami prostatectomy mai raɗaɗi ko ≥ 5.0 ng/mL ga waɗanda ke da maganin radiation na farko.
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
