page contents
  • Anne

Jan. 2022 News Updates

Updated: Jan 1

An Experimental Drug Called Elacestrant May be FDA-Approved This Year!

Possibly the most pivotal news divulged at the San Antonio Breast Cancer Symposium in Dec. 2021 was a study of an endocrine therapy drug called Elacestrant for patients with HR+, HER2- MBC. Elacestrant is an oral SERD (Selective Estrogen Receptor Degrader) somewhat similar to (but different than) Faslodex, an FDA-approved SERD that is injected in the buttocks. The Phase 3 EMERALD trial enrolled 477 postmenopausal patients who had received one or two prior lines of endocrine therapy without chemotherapy in the metastatic setting. All patients had progressed on prior CDK4/6 inhibitor treatment. Patients were randomized to receive either Elacestrant or standard of care endocrine therapy consisting of either Faslodex or an Aromatase Inhibitor. At 6 months, the median Progression Free Survival (PFS) for patients taking Elacestrant was 34.3%, vs. 20.4% for patients taking the standard of care. For patients with ESR1 mutations, PFS at 6 months was 40.8% for patients taking Elacestrant vs. 19.1% for patients taking the standard of care.

Researchers acknowledged a study limitation in that all patients enrolled received prior CDK 4/6 inhibitor treatment, so the clinical benefit of Elacestrant for patients who have not received CDK 4/6 inhibitor therapy is undetermined. Given these results, it is possible that Elacestrant may be FDA-approved for a subset of HR+, HER2- patients in 2022. From: Elacestrant extends PFS among certain women with metastatic breast cancer (

1,165 views0 comments

Recent Posts

See All

Enhertu has already been approved for HER2 positive MBC patients who relapsed on prior treatment, and is being assessed for HER2 low patients. HR+, HER2- and TNBC patients have either HER2 low express

Enhertu, which has shown statistically significant improvement in PFS when compared with Kadcyla (TDM1) as second-line treatment for HER2-positive MBC, has now been FDA-approved for HER2 positive adul