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Veru Announces FDA Grant of Fast Track Designation for Enobosarm for the Treatment of AR+ ER+ HER2- Metastatic Breast Cancer
-- FDA Fast Track Designation is Intended to Expedite the Development and Review of New Drugs to Treat Serious Medical Conditions that Fill Unmet Medical Need
About this update from Veru Inc.
[{"type":"text","content":"-- FDA Fast Track Designation is Intended to Expedite the Development and Review of New Drugs to Treat Serious Medical Conditions that Fill Unmet Medical Need -- -- Phase 3 ARTEST Registration Study of Enobosarm in Patients with AR+ ER+ HER2- Metastatic Breast Cancer Who Have Shown Previous Disease Progression on a Nonsteroidal AI, Fulvestrant, and a CDK 4/6 Inhibitor is Currently Enrolling -- MIAMI, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Phase 3 registration program for the investigation of enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, fulvestrant, and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting). “We are very pleased that enobosarm has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. “We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.” About Fast Track DesignationFast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. The purpose is to get important new drugs to patients faster. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Drugs that are granted this designation are given the opportunity for more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval: more frequent written communication wit...