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 ...
What Is Inluriyo, and Why Does It Matter? Inluriyo (imlunestrant) is a new oral treatment for certain types of locally advanced or metastatic breast cancer that has progressed after at least one round ...
Elacestrant significantly improves PFS in ER-positive, HER2-negative metastatic breast cancer with ESR1 mutations compared to standard-of-care treatments. The EMERALD trial showed elacestrant's ...
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — Too often, cancer has a way of evading ...
Mutations in ESR1 do not appear to confer breast cancer resistance to cyclin-dependent kinase (CDK)4/6 inhibitors, an analysis of clinical practice data suggested. Patients with metastatic hormone ...
A Prescription Drug User Fee Act target date of June 5, 2026 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...
Dr Lu discusses whether ESR1 mutation confirmation is required to consider therapy with oral selective estrogen receptor degraders. Ryan Haumschild, PharmD, MS, MBA: Calling out the treatment pathways ...
The Food and Drug Administration will fast-track the development of AC699 for patients with ER-positive, HER2-negative ESR1-mutant advanced or metastatic breast cancer. The Food and Drug ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Inluriyo ( imlunestrant, Eli Lilly Nederland B.V.) be given marketing ...
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