Menarini group's elacestrant granted priority review by the u.s. fda for patients with er+/her2- advanced or metastatic breast cancer

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (serd) to be available for patients suffering from 2l and 3l er+/her2- advanced or metastatic breast cancer submission supported by results from the pivotal phase 3 emerald study of elacestrant showing statistically significant efficacy over current standard-of-care (soc) medications for both the overall study population and patients whose tumors harbor an esr1 mutation u.s. fda has assigned a prescription drug user fee act (pdufa) date of february 17, 2023 florence, italy and new york, aug. 11, 2022 /prnewswire/ -- the menarini group ("menarini"), a privately held italian pharmaceutical and diagnostics company, and stemline therapeutics ("stemline"), a wholly-owned subsidiary of menarini group, today announced that the u.s. food and drug administration (fda) has accepted the company's new drug application (nda) for elacestrant, an investigational selective estrogen receptor degrader (serd), for patients with er+/her2- advanced or metastatic breast cancer. the fda has granted the application priority review and assigned a pdufa date of february 17, 2023.
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