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FDA Greenlights Imaging Agent to Detect Residual Cancer After Lumpectomy

In In The News by Barbara Jacoby

By: Charles Bankhead From: medpagetoday.com The FDA approved pegulicianine (LumiSight) as an optical imaging agent for detecting residual cancer after breast-conserving surgery (BCS). The approvalopens in a new tab or window stipulates use of pegulicianine with the Lumicell Direct Visualization System (DVS) or another fluorescence imaging device approved for use with pegulicianine. The fluorescent dye is administered intravenously before surgery. …

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FDA Greenlights First Drug for ESR1-Mutated Breast Cancer

In In The News by Barbara Jacoby

By: Charles Bankhead From: medpagetoday.com The FDA approved the selective estrogen receptor (ER) degrader elacestrant (Orserdu) for the treatment of 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. The FDA also approved the Guardant360 CDx assay as a companion diagnostic test to identify …