On May 4, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported an update on its pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes (Press release, Eagle Pharmaceuticals, MAY 4, 2020, View Source [SID1234556949]).
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"As discussed on our March 2nd earnings call, we have continued to refine our EA-114 program, collected additional pilot data, and are pleased with our progress. We have had two meetings with FDA and will request another meeting to discuss these data. With FDA’s guidance, we hope to move ahead with our plans. We look forward to providing additional updates on the progress of this potential drug treatment for hormone-receptor ("HR")-positive advanced breast cancer," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
"A substantial number of women with advanced HR-positive breast cancer receiving standard treatment experience early disease progression," said Adrian Hepner, Chief Medical Officer of Eagle Pharmaceuticals. "Low and inconsistent estrogen receptor inhibition often results in suboptimal treatment, which may lead to faster progression of the disease. Our research suggests that we may have a better approach."
About Fulvestrant
Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the FDA for the treatment of advanced hormone-related breast cancers. The therapeutic effect of fulvestrant involves its ability to competitively inhibit estrogen-stimulated cell division by binding to the ERs in cancer cells, which may reduce cancer cell proliferation.
Fulvestrant is indicated as a monotherapy treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy, or as a combination therapy for the treatment of: (1) 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, or (2) HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with palbociclib or abemaciclib, in women with disease progression after endocrine therapy.
About Breast Cancer
Breast cancer is the most commonly diagnosed cancer in women, with approximately 290,000 women diagnosed in the U.S. annually and more than 2.8 million breast cancer survivors in the U.S. today. HR-positive breast cancer is the most common clinical subtype, with the ER being expressed in approximately 75% of those diagnosed.