I-Enzalutamide igunyazwe yi-USFDA yomdlavuza wendlala yesinye ongeyena-metastatic castration-sensitive kanye nokuphindaphinda kwamakhemikhali e-biochemical

I-FDA igunyaze i- enzalutamide yokwelapha umdlavuza wendlala yesinye ongeyena-metastatic castration-sensitive ezimeni zokuphindaphinda kwamakhemikhali ezinto eziphilayo.

I-Food and Drug Administration igunyaze i-anzelutamide (Xtandi, Astellas Pharma US, Inc.) yomdlavuza wendlala yesinye we-non-metastatic castration-sensitive (nmCSPC) onokuphindeka kwe-biochemical engozini enkulu ye-metastasis (i-BCR enobungozi obukhulu) ngoNovemba 16, 2023.

Ukusebenza kwahlolwa ku-EMBARK (NCT02319837), ucwaningo lomtholampilo olungahleliwe, olulawulwayo olubandakanya iziguli ze-1068 ezinomdlavuza we-prostate ongenayo i-metastatic castration-sensitive kanye nokuphindaphinda kwe-biochemical engozini enkulu. Zonke iziguli zake zenziwa i-radical prostatectomy kanye/noma ngemisebe ngenjongo yokwelapha ngaphambili, zinesikhathi sokuphinda kabili i-PSA esiyizinyanga ezingu-9 noma ngaphansi, futhi zazingafaneleki ukuthola i-salvage radiotherapy lapho zijoyina ucwaningo. Abahlanganyeli babelwa ngokungahleliwe ngesilinganiso esingu-1:1:1 ukuze bathole i- enzalutamide 160 mg kanye ngosuku kanye ne-leuprolide ngendlela yokungaboni, enzalutamide 160 mg kanye ngosuku njenge-ejenti eyodwa ngendlela enelebula elivulekile, noma i-placebo ephuphuthekile kanye ngosuku. kanye ne-leuprolide.

Umphumela oyinhloko ofundwe ocwaningweni kwaba ukusinda kwe-metastasis-free (MFS), okuhlolwe ukubuyekezwa okumaphakathi okungachemile, kuqhathanise i-enzelutamide ne-leuprolide ne-placebo kanye ne-leuprolide. Izinyathelo ezengeziwe zemiphumela esebenza ngempumelelo kube ukusinda kokungaphumeleli okumaphakathi (MFS) kwe enzalutamide monotherapy uma kuqhathaniswa ne-placebo + leuprolide kanye nokusinda sekukonke (OS).

I-Enzalutamide kanye ne-leuprolide ibonise ukuthuthuka okuphawulekayo kwezibalo ekusindeni kwe-metastasis uma kuqhathaniswa ne-placebo kanye ne-leuprolide, enesilinganiso sengozi esingu-0.42 kanye nenani le-p elingaphansi kuka-0.0001. I-Enzalutamide monotherapy ibonise ukuthuthuka okuphawulekayo kwezibalo ekusindeni kwe-metastasis uma kuqhathaniswa ne-placebo kanye ne-leuprolide, enesilinganiso sengozi esingu-0.63 (95% CI: 0.46, 0.87; p-value = 0.0049). Ngesikhathi sokuhlaziywa kwe-MFS, idatha ye-OS ibingaphelele, ikhombisa izinga lokufa elingu-12% esiphelele sabantu.

Imiphumela engemihle evamile (≥ 20% izehlakalo) kubantu abalashwa nge- enzalutamide kuhlanganiswe ne-leuprolide kwaba ukushibilika, ubuhlungu bemisipha namathambo, ukukhathala, ukuwa, nokopha. Imiphumela engemihle evamile ye-anzelutamide monotherapy ihlanganisa ukukhathala, i-gynecomastia, ubuhlungu bemisipha namathambo, ukuthamba kwebele, ukushisa okushisayo nokopha.

Umthamo ophakanyisiwe we enzalutamide ngu-160 mg othathwa ngomlomo kanye ngosuku, ngokudla noma ngaphandle kokudla, kuze kube yilapho ukugula kuqhubeka noma ubuthi obungamukeleki. I-Enzalutamide inganikezwa nge-analog ye-GnRH noma ngaphandle kwayo. Imithi ye-Enzalutamide ingase imiswe uma amazinga e-PSA engaphansi kuka-0.2 ng/mL ngemva kwamasonto angu-36 okwelashwa. Ukwelashwa kungaqalwa kabusha lapho amazinga e-PSA efinyelela> ku-2.0 ng/mL kubantu abathile abakhishwe i-prostatectomy eqinile noma ≥ 5.0 ng/mL kulabo abanokwelashwa okuyisisekelo ngemisebe.