Regulatory approval

Published by the Food and Drug Administration. Approved

FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.

This is written in the approval document.

Citation

AstraZeneca UK Limited. Faslodex (fulvestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf. Revised January 2021. Accessed October 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Fulvestrant, Ribociclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib