| Abstrakt: |
The US Food and Drug Administration (FDA) has approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer. The approval was based on a randomized trial involving 478 patients with ER+, HER2- advanced or metastatic breast cancer, including 228 patients with ESR1 mutations. The study showed a statistically significant improvement in progression-free survival (PFS) in the ESR1-mut subgroup. However, more patients who received elacestrant experienced nausea, vomiting, and dyslipidemia. The approval of elacestrant is restricted to patients with ESR1 mutations. This is the first oral estrogen receptor antagonist to receive FDA approval for patients with ESR1 mutations. [Extracted from the article] |
