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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 (healio.com)

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