Enobosarm Gets Fast Track Status for AR+ER+HER2- Metastatic Breast Cancer

The Food and Drug Administration (FDA) has granted Fast Track designation to enobosarm for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer in patients who have shown previous disease progression on a nonsteroidal aromatase inhibitor, fulvestrant, and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining of at least 40% in breast cancer tissue (third-line metastatic setting).

Enobosarm is an oral, first-in-class, selective androgen receptor agonist. The Company is currently evaluating the efficacy and safety of enobosarm as monotherapy for AR+ER+HER2- metastatic breast cancer in the phase 3 ARTEST study (ClinicalTrials.gov Identifier: NCT04869943). The primary efficacy endpoint is median radiographic progression free survival.

“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.”

The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.

A phase 3 trial (ENABLAR-2) evaluating enobosarm plus abemaciclib for the treatment of second-line metastatic AR+ER+HER2- breast cancer that has progressed after treatment with palbociclib and either a nonsteroidal aromatase inhibitor or fulvestrant combination with an androgen receptor nuclei staining of greater than or equal to 40% is also being planned. Additionally, the Company will evaluate the combination of enobosarm and sabizabulin (a new chemical entity) in women with metastatic triple negative breast cancer that have become resistant to at least 2 systemic chemotherapies in a phase 2 study.


Veru announces FDA grant of Fast Track designation for enobosarm for the treatment of AR+ ER+ HER2- metastatic breast cancer. News release. Veru Inc. Accessed January 10, 2022. https://www.globenewswire.com/news-release/2022/01/10/2364044/11676/en/Veru-Announces-FDA-Grant-of-Fast-Track-Designation-for-Enobosarm-for-the-Treatment-of-AR-ER-HER2-Metastatic-Breast-Cancer.html