NgoFebhuwarirkanye no-2023, I-Food and Drug Administration (FDA) igunyaze i-elacestrant (i-Orserdu, i-Stemline Therapeutics, Inc.) kwabesifazane noma amadoda angaphezu kweminyaka engama-50 abanomdlavuza webele othuthukile noma we-metastatic futhi ane-ER-positive, HER2-negative, futhi anezinguquko ze-ESR1. Lesi sifo siqhubekele phambili ngemuva okungenani komugqa owodwa wokwelashwa kwe-endocrine.
I-Guardant360 CDx assay iphinde yanikezwa imvume ye-FDA njengethuluzi lokuxilonga elihambisana nokwelapha iziguli ezinomdlavuza webele.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic umdlavuza webele in whom 228 patients had ESR1 mutations, investigated the effectiveness of the treatment. Patients had to have seen disease progression after receiving one or more lines of endocrine therapy in the past, including at least one line that contained a CDK4/6 inhibitor. Patients who were eligible could have had up to one prior line of chemotherapy for advanced or metastatic disease. Elacestrant 345 mg orally once daily was given to patients who were randomly assigned (1:1) to receive it or investigator’s choice of endocrine therapy, which included fulvestrant (n=166) or an aromatase inhibitor (n=73). ESR1 mutation status (found vs. not found), previous fulvestrant treatment (yes vs. no), and visceral metastasis were used to divide the patients into groups for randomization (yes vs. no). The Guardant360 CDx assay was used to identify ESR1 missense mutations in the ligand binding domain and was limited to blood circulating tumour deoxyribonucleic acid (ctDNA).
Isilinganiso esiyinhloko somphumela wokusebenza ngempumelelo kwaba i-progression-free survival (PFS), eyahlolwa yikomidi elibukeza izithombe elingaboni. Esibalweni sabantu abane-ITT kanye neqembu elincane leziguli ezinezinguquko ze-ESR1, kube nomehluko ophawulekayo wezibalo ku-PFS.
I-PFS emaphakathi kwakuyizinyanga ezingu-3.8 (95% CI: 2.2, 7.3) kuziguli ezingu-228 (48%) ezinezinguquko ze-ESR1 eziphathwe nge-elacestrant kanye nezinyanga ezingu-1.9 (95% CI: 1.9, 2.1) kulabo abaphathwa nge-fulvestrant noma i-aromatase inhibitor. (isilinganiso sengozi [HR] yokungu-0.55 [95% CI: 0.39, 0.77], 2-sided p-value=0.0005).
Iziguli ezingama-250 (52%) ezingenazo izinguquko ze-ESR1 ekuhlaziyweni kokuhlola kwe-PFS zine-HR engu-0.86 (95% CI: 0.63, 1.19) ebonisa ukuthi imiphumela ebonwe ku-ESR1 yabantu abaguqukayo yayinomthwalo omkhulu wokuthuthukisa iqoqo le-ITT. .
Ubuhlungu be-musculoskeletal, isicanucanu, i-cholesterol ephakeme, i-AST ephakanyisiwe, i-triglycerides ephakeme, ukukhathala, ukwehla kwe-hemoglobin, ukuhlanza, i-ALT ephakeme, i-sodium ephakeme, i-creatinine ephakeme, ukuncipha kwesifiso sokudla, isifo sohudo, ikhanda elibuhlungu, ukuqunjelwa, ubuhlungu besisu, ukushisa okushisayo, kanye ne-dyspepsia. izehlakalo ezimbi ezivamile (10%), okuhlanganisa nokungajwayelekile elabhorethri.
Kunconywa ukuthi uphuze ama-345 mg we-elacestrant kanye ngosuku ngokudla kuze kube yilapho isifo siqhubeka noma ubuthi bungabekezeleleki.
View full prescribing information for Orserdu.
