FDA Approves ORSERDU — Stemline Therapeutics, Inc.

Stemline Therapeutics, Inc. announced on January 27, 2023, that the FDA approved its oral selective estrogen receptor degrader (SERD) Elacestrant under the brand name ORSERDU, establishing a critical fourth, or 'fourth-line,' therapeutic option for patients with advanced ER+/HER2- breast cancer. This clearance is anticipated to create significant market competition against leading endocrine therapies like olaparib, potentially reshaping treatment algorithms and influencing market share allocation in the growing hormonal fixed-combination landscape.