Jan. 27 Quick Takes: FDA approves first oral SERD

Orserdu elacestrant from Menarini Group became the first oral selective estrogen receptor degrader (SERD) approved in the U.S. with the FDA approval of the therapy in second-line ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. In 228 patients with ESR1 mutations in the EMERALD trial, median progression-free survival (PFS) was 3.8 months for patients receiving elacestrant and 1.9 months for those receiving fulvestrant or aromatase inhibitor therapy.

After years of failures for oral, next-generation SERDs seeking to displace fulvestrant, the sole marketed member of the class, the approval marks a milestone for the class. The spotlight is now on camizestrant, which demonstrated 7.7 months of PFS, versus fulvestrant’s 3.7 months, in the Phase II SERENA study. Results were reported at the San Antonio Breast Cancer Symposium (SABCS) last month...