On December 9, 2019 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the Company has commenced dosing in a pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, which has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes (Press release, Eagle Pharmaceuticals, DEC 9, 2019, View Source [SID1234552114]). The results of the pilot study will inform the design of the Company’s pivotal trial, which Eagle expects to commence in 2020.
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"We are pleased that dosing is underway in our pilot study, and look forward to gathering data to determine the design of our future pivotal study in estrogen receptor positive breast cancer patients. We believe there is a sizable patient population who could benefit from our product’s differentiated characteristics, and we look forward to expanding our portfolio of oncology assets," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
About Fulvestrant
Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the U.S. Food and Drug Administration for the treatment of advanced hormone-related breast cancers. The therapeutic effect of fulvestrant relies on its ability to inhibit ERs in cancer cells by binding to and downregulating, or blocking, the ER in breast cancer cells. Recent studies have shown that higher residual ER availability is associated with early disease progression.
Fulvestrant is indicated as a monotherapy treatment of hormone receptor (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. Hormone receptor-positive (HR+) breast cancer is the most common clinical subtype, with the ER being expressed in approximately 75% of those diagnosed.