Fevral oyidary 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for women or men over 50 who have advanced or metastatic breast cancer and are ER-positive, HER2-negative, and have ESR1 mutations. The disease has progressed after at least one line of endocrine therapy.
Guardant360 CDx tahlili, shuningdek, ko'krak bezi saratoni bilan og'rigan bemorlarni elastik davolash uchun qo'shimcha diagnostika vositasi sifatida FDA tomonidan tasdiqlangan.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic ko'krak saratoni 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).
The main efficacy outcome measure was progression-free survival (PFS), which underwent evaluation by a blinded imaging review committee. In the population with ITT and in the subgroup of patients with ESR1 mutations, there was a statistically significant difference in PFS.
Elasestrant bilan davolangan ESR3.8 mutatsiyalari bo'lgan 95 (2.2%) bemorlar uchun o'rtacha PFS 7.3 oyni (228% CI: 48, 1) va fulvestrant yoki aromataza inhibitori bilan davolanganlar uchun 1.9 oyni (95% CI: 1.9, 2.1) tashkil etdi. (xavf darajasi [HR] 0.55 [95% CI: 0.39, 0.77], 2 tomonlama p-qiymati = 0.0005).
PFS tadqiqotida ESR250 mutatsiyasiga ega bo'lmagan 52 (1%) bemorlarda HR 0.86 (95% CI: 0.63, 1.19) bo'lgan, bu esa ESR1 mutant populyatsiyasida ko'rilgan natijalar ITT kohortidagi yaxshilanish uchun asosan javobgar ekanligini ko'rsatadi. .
Tayanch-harakat tizimidagi og‘riqlar, ko‘ngil aynishi, xolesterinning ko‘tarilishi, AST ko‘tarilishi, triglitseridlarning ko‘payishi, charchoq, gemoglobinning kamayishi, qusish, ALT ning ko‘tarilishi, natriyning ko‘tarilishi, kreatininning ko‘tarilishi, ishtahaning pasayishi, diareya, bosh og‘rig‘i, ich qotishi, qorin bo‘shlig‘ida isitma, isitma, isitma, ko‘p og‘riqlar. tez-tez uchraydigan noxush hodisalar (10%), shu jumladan laboratoriya anormalliklari.
Kasallik kuchayguncha yoki toksiklik chidab bo'lmas holga kelgunga qadar kuniga bir marta 345 mg elasestrantni ovqat bilan birga qabul qilish tavsiya etiladi.
View full prescribing information for Orserdu.
