FDA approves Italy-based pharma's oral SERD for some breast cancer patients

30 Jan 2023
endpts.com
Phase 3Phase 2Clinical ResultFast TrackDrug Approval
The breast cancer drug Orserdu has been approved by the FDA, opening up a new line of next-generation treatment for certain patients as other, larger companies have tried and failed to develop an effective oral SERD. Italian pharma Menarini Group and its New York City subsidiary Stemline Therapeutics submitted the NDA in June for what the company claims is the first oral selective estrogen receptor degraderestrogen receptor degrader, or SERD, for second- and third-line treatment of ER+/HER2- advanced or metastatic breast cancer. It’s approved for postmenopausal women or adult men whose disease is still progressing even after at least one line of endocrine therapy. The recommended dosage of Orserdu is one 345 mg tablet taken orally, once daily, with food. Menarini bought the drug, known then as elacestrant, a few years ago for $30 million from Radius Health as the race to develop an oral SERD heated up. Orserdu earned both priority review and fast track designation. The approval comes after positive data from the EMERALD study, where the drug achieved both primary endpoints in a study of patients with ER+/HER2- breast cancer. The drug beat the standard of care for progression-free survival in the overall population and PFS with tumors harboring estrogen receptor 1 mutations, or ESR1. Fuller data from the trial showed the efficacy was much higher for patients harboring the ESR1 mutations, piquing investor interest. MenariniMenarini also submitted a marketing application to the European Medicines Agency in July. In the same breath as the Orserdu approval, the FDA also announced it approved the Guardant360 CDx assay as a diagnostic device to identify patients with breast cancer for treatment with elacestrant. Other companies have tried and failed to develop an effective oral SERD: Sanofi failed its first big test for its SERD amcenestrant after it didn’t meet its progression free survival endpoints in March of last year. Roche also flunked out in a Phase II in April 2022 and G1 Therapeutics ended its program and bowed out of the race after scoping out the data and potential partners. Other oral SERDs are also in development, including AstraZeneca’s camizestrant . The company is testing the drug in a few Phase III trials after a positive readout in the SERENA-2 Phase II trial. AstraZeneca developed another line of treatment, an injectable SERD called fulvestrant, which earned an approval for HER2- advanced breast cancerHER2- advanced breast cancer in 2017.
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