Oserdu – pro
Orserdu is a new oral SERD for metastatic, estrogen receptor-positive breast cancer. The FDA has approved Orserdu (elacestrant) to treat postmenopausal women or adult men with advanced or metastatic breast cancer. It is indicated for patients with ER-positive, HER2-negative, ESR1-mutated disease with disease progression following at least one line of endocrine therapy.
THe drug is FDA approved for this claimant’s situation and is a differently acting drug that is more likely to be effective than older-class drugs in this multiple-treated situation. Approval was based on data from the phase 3 EMERALD study, a multicenter trial that enrolled 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer of which 228 patients had ESR1 mutations. The study compared Orserdu with AstraZeneca’s Faslodex (fulvestrant), the only other FDA-approved SERD, plus letrozole, anastrozole, exemestane.
In the 228 (48%) patients with ESR1 mutations, median progression-free survival was 3.8 months in the Orserdu arm and 1.9 months in the Faslodex arm. An exploratory analysis of progression-free survival in the 250 (52%) patients without ESR1 mutations showed a hazard ratio of 0.86, indicating that the improvement
Dustin D, Gu G, Fuqua SAW. ESR1 mutations in breast cancer. Cancer. 2019;125(21):3714-3728. doi:10.1002/cncr.32345
Turner NC, Swift C, Kilburn L, et al. ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor-positive breast cancer: A Combined Analysis of the Phase III SoFEA and EFECT Trials. Clin Cancer Res. 2020;26(19):5172-5177. doi:10.1158/1078-0432.CCR-20-0224Di Leo A, Jerusalem G, Petruzelka L, et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2010;28(30):4594-4600. doi:10.1200/JCO.2010.28.8415
Oserdu, Prescribing Information 2023