Enzalutamide inotenderwa neUSFDA kune isiri-metastatic castration-sensitive cancer yeprostate ine biochemical kudzokorora.

Iyo FDA yakabvumidza enzalutamide kurapwa kweiyo isiri-metastatic castration-sensitive cancer yeprostate mune zviitiko zvebiochemical kudzoka.

Chikafu neDrug Administration yakabvumidza enzalutamide (Xtandi, Astellas Pharma US, Inc.) kune isiri-metastatic castration-sensitive cancer yeprostate (nmCSPC) ine biochemical kudzokorora panjodzi huru ye metastasis (yakanyanya-njodzi BCR) muna Mbudzi 16, 2023.

Kubudirira kwakaongororwa muEMBARK (NCT02319837), chidzidzo chekliniki chisingaverengeki, chinodzorwa chinosanganisira varwere ve1068 vane non-metastatic castration-sensitive kenza yeprostate uye yakakwirira-njodzi biochemical recurrence. Varwere vese vakange vaita radical prostatectomy uye/kana mwaranzi nechinangwa chekurapa kare, vaive nePSA yakapetwa kaviri mwedzi ye9 kana pasi, uye vaive vasingakodzeri kuwana radiotherapy pavakapinda muchidzidzo. Vatori vechikamu vakapihwa zvisina tsarukano muchiyero che1:1:1 kuti vagamuchire enzalutamide 160 mg kamwe pazuva pamwe chete neleuprolide nenzira yakapofumadzwa, enzalutamide 160 mg kamwe chete pazuva semumiriri mumwechete nenzira yakavhurika-label, kana placebo yakapofumadzwa kamwe chete pazuva. pamwe chete neleuprolide.

Mhedzisiro yekutanga yakadzidzwa muchidzidzo yaive metastasis-isina kupona (MFS), yakaongororwa nekusarerekera kwepakati wongororo, kuenzanisa enzalutamide neleuprolide kune placebo pamwe neuprolide. Kuwedzera kushanda kwemhedzisiro matanho aive epakati kutadza-kusununguka kupona (MFS) ye enzalutamide monotherapy kana ichienzaniswa ne placebo + leuprolide uye kupona kwese (OS).

Enzalutamide pamwe neleuprolide yakaratidza kuvandudzwa kwenhamba mukurarama kusina metastasis kana ichienzaniswa neplacebo pamwe neleuprolide, ine ngozi ine 0.42 uye p-value isingasviki 0.0001. Enzalutamide monotherapy yakaratidza kuvandudzika kwakakosha mukupona-pasina metastasis kana ichienzaniswa ne placebo plus leuprolide, ine hazard ratio ye0.63 (95% CI: 0.46, 0.87; p-value = 0.0049). Munguva yekuongorora kweMFS, data yeOS yakanga isina kukwana, ichiratidza 12% yehuwandu hwekufa muhuwandu hwevanhu.

Zvakajairwa mhedzisiro (≥ 20% chiitiko) muvanhu vanorapwa ne enzalutamide pamwe neleuprolide vaipisa kupisa, kurwadziwa musculoskeletal, kuneta, kudonha, uye kubuda ropa. Zvakajairika mhedzisiro ye enzalutamide monotherapy inosanganisira kuneta, gynecomastia, kurwadziwa kwetsandanyama, kupfava kwezamu, kupisa kupisa, uye kubuda ropa.

Iyo yakataurwa enzalutamide dosage ndeye 160 mg inotorwa nemuromo kamwe chete pazuva, ine kana pasina chikafu, kusvika hurwere hwakura kana muchetura usingagamuchirike. Enzalutamide inogona kupihwa ine kana isina analogi yeGnRH. Enzalutamide mishonga inogona kumiswa kana mazinga ePSA ari pasi pe0.2 ng/mL mushure memavhiki makumi matatu nematanhatu ekurapwa. Kurapa kunogona kutangwa patsva kana mazinga ePSA asvika> 36 ng/mL kune vanhu vakaita radical prostatectomy kana ≥ 2.0 ng/mL kune avo vane primary radiation therapy.