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FDA Grants Fast Track Designation for Enobosarm for the Treatment of AR+ ER+ HER2- Metastatic Breast Cancer

January 10, 2022 • 10:13 am CST
(Vax Before Cancer)

Florida-based Veru Inc. 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,” commented Mitchell Steiner, M.D., Chairman, President and Chief EEO of Veru Inc., in a press release.

“We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”

Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor in AR+ ER+ HER2- metastatic breast cancer without unwanted masculinizing side effects.