Posted by Michael Wonder on 11 Jan 2022
Veru announces FDA grant of fast track designation for enobosarm for the treatment of androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer
10 January 2022 - Phase 3 ARTEST registration study of enobosarm in patients with androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer who have shown previous disease progression on a non-steroidal aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is currently enrolling.
Veru today announced that the U.S. 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, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer patients who have shown previous disease progression on a non-steroidal aromatase inhibitor, fulvestrant, and CDK 4/6 inhibitor therapy, and who have androgen receptor nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).
