A cikin Fabrairury 2023, Cibiyar Abinci da Magunguna (FDA) ta amince da elacestrant (Orserdu, Stemline Therapeutics, Inc.) ga mata ko maza fiye da 50 waɗanda suka ci gaba ko ciwon nono na ciwon daji kuma suna da ER-positive, HER2-negative, kuma suna da ESR1 maye gurbi. Cutar ta ci gaba bayan akalla layi daya na maganin endocrin.
Guardant360 CDx assay kuma an ba da izinin FDA a matsayin kayan aikin bincike na abokin don haɓakar jiyya na marasa lafiya da ciwon nono.
EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic ciwon nono 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).
Babban ma'aunin sakamako na inganci shine tsira ba tare da ci gaba ba (PFS), wanda kwamitin nazarin hoto mai makanta ya gwada shi. A cikin yawan jama'a tare da ITT da kuma a cikin rukunin marasa lafiya tare da maye gurbin ESR1, akwai bambanci mai mahimmanci a cikin PFS.
Matsakaicin PFS shine watanni 3.8 (95% CI: 2.2, 7.3) don 228 (48%) marasa lafiya tare da maye gurbin ESR1 da aka bi da su tare da elacestrant da watanni 1.9 (95% CI: 1.9, 2.1) ga waɗanda aka bi da su tare da fulvestrant ko mai hana aromatase (haɗarin haɗari [HR] na 0.55 [95% CI: 0.39, 0.77], 2-gefe p-darajar = 0.0005).
Marasa lafiya na 250 (52%) ba tare da maye gurbin ESR1 ba a cikin binciken bincike na PFS suna da HR na 0.86 (95% CI: 0.63, 1.19) yana nuna cewa sakamakon da aka gani a cikin yawan mutant ESR1 sune ke da alhakin haɓakawa a cikin ƙungiyar ITT. .
Ciwon musculoskeletal, tashin zuciya, haɓakar cholesterol, haɓakar AST, haɓakar triglycerides, gajiya, raguwar haemoglobin, amai, haɓakar ALT, haɓakar sodium, haɓakar creatinine, raguwar ci, zawo, ciwon kai, maƙarƙashiya, ciwon ciki, zafi mai zafi, da dyspepsia sune suka fi yawa. m aukuwa akai-akai (10%), gami da rashin daidaituwa na dakin gwaje-gwaje.
Ana ba da shawarar shan 345 MG na elacestrant sau ɗaya kowace rana tare da abinci har sai cutar ta ci gaba ko kuma rashin lafiyar ya zama mai yiwuwa.
View full prescribing information for Orserdu.
