Veru Inc. 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).
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- Veru Inc. Announces FDA Grant of Fast Track Designation for Enobosarm for the Treatment of AR+ ER+ HER2- Metastatic Breast Cancer