Muna Februaryry 2023, Food and Drug Administration (FDA) yakabvumira elacestrant (Orserdu, Stemline Therapeutics, Inc.) yevakadzi kana varume vanopfuura makumi mashanu vane kenza yepazamu yepamusoro kana metastatic uye vane ER-positive, HER50-negative, uye vane ESR2 mutations. Chirwere chave chichienderera mberi mushure memutsara mumwe chete we endocrine therapy.
Iyo Guardant360 CDx assay yakapihwawo mvumo yeFDA sechishandiso chekuongorora chekurapa kwekurapa kwevarwere vane cancer yemazamu.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial yaisanganisira 478 postmenopausal vakadzi nevarume vane advanced or metastatic. kenza yebonde mune varwere 228 vaive neESR1 mutations, vakaongorora kushanda kwekurapa. Varwere vaifanira kunge vaona kufambira mberi kwechirwere mushure mekugamuchira imwe kana kupfuura mitsara ye endocrine therapy munguva yakapfuura, kusanganisira kamwechete mutsara waiva neCDK4/6 inhibitor. Varwere vaikodzera vaigona kunge vaine mutsara wekutanga wechemotherapy yechirwere chepamusoro kana metastatic. Elacestrant 345 mg muromo kamwe chete zuva nezuva yakapiwa kuvarwere vakanga vapiwa (1: 1) kuti vagamuchire kana kuti sarudzo yemuongorori ye endocrine therapy, iyo yaisanganisira fulvestrant (n = 166) kana aromatase inhibitor (n = 73). ESR1 mutation mamiriro (yakawanikwa vs. isina kuwanikwa), yapfuura fulvestrant kurapwa (hongu vs. kwete), uye visceral metastasis yakashandiswa kuparadzanisa varwere mumapoka e randomisation (hongu vs. kwete). Iyo Guardant360 CDx assay yakashandiswa kuona ESR1 missense mutations mune ligand binding domain uye yaingogumira kuropa rinotenderera bundu deoxyribonucleic acid (ctDNA).
Chiyero chikuru chemhedzisiro chiyero chaive kufambira mberi-kusina kupona (PFS), iyo yakaongororwa nekomiti yakapofumadzwa yekuongorora yekufungidzira. Muhuwandu hwevanhu vane ITT uye muboka revarwere vane ESR1 mutations, pakanga pane mutsauko wakakosha muPFS.
Iyo yepakati PFS yaive mwedzi 3.8 (95% CI: 2.2, 7.3) ye228 (48%) varwere vane ESR1 mutations inobatwa ne elacestrant uye 1.9 mwedzi (95% CI: 1.9, 2.1) kune avo vanobatwa ne fulvestrant kana aromatase inhibitor. (hazard ratio [HR] ye0.55 [95% CI: 0.39, 0.77], 2-sided p-value=0.0005).
Varwere mazana maviri nemakumi mashanu (250%) vasina kuchinja kweESR52 muongororo yekuongorora yePFS vaive neHR ye1 (0.86% CI: 95, 0.63) zvichiratidza kuti mhedzisiro yakaonekwa muESR1.19 mutant population ndiyo inonyanya kukonzera kuvandudzwa kweITT cohort. .
Marwadzo emusculoskeletal, kusvotwa, cholesterol yakakwira, yakakwira AST, yakakwira triglycerides, kuneta, kuderera kwehemoglobin, kurutsa, yakakwira ALT, yakakwira sodium, yakakwira creatinine, kuderera kwechido, manyoka, kutemwa nemusoro, kuvimbiswa, kurwadziwa mudumbu, kupisa kwemhepo, uye dyspepsia yakanyanya. zvinowanzoitika zvakashata (10%), kusanganisira kukanganisa kwerabhoritari.
Inorayirwa kutora 345 mg ye elacestrant kamwe chete zuva nezuva nechikafu kusvikira chirwere chacho chakura kana kuti chepfu inosagadzikana.
Wona ruzivo rwakazara rwekurayira Orserdu.
