Orserdu & companion diagnostic for ER+, HER2-, ESR1-mutated advanced breast cancer receive FDA approval

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FDA approved Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

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Positive high-level results from the Tropion-Breast02 phase III trial showed Datroway (datopotamab deruxtecan-dlnk) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival compared to investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option.
From left to right: Geoffrey Shapiro, Leif Ellisen and Nancy Lin. Sitting below them is Kornelia Polyak.The Dana-Farber/Harvard Cancer Center,  a cancer research consortium comprised of five of Boston’s academic medical centers, including Dana-Farber Cancer Institute and Massachusetts General Hospital, has been awarded an NCI grant to continue its Specialized Program of Research Excellence in Breast Cancer.

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