FDA Brief: Fast Track Designation Granted to Enobosarm in Metastatic Breast Cancer

By: JNCCN 360 Staff
Posted: Monday, January 17, 2022

On January 10, the biopharmaceutical company Veru Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the phase III registration program for the investigation of enobosarm—an oral selective androgen receptor agonist—in the treatment of patients with androgen receptor–positive, estrogen receptor–positive, HER2-negative metastatic breast cancer. These patients must have experienced disease progression on a nonsteroidal aromatase inhibitor, fulvestrant, and CDK4/6 inhibitor therapy as well as have at least 40% androgen receptor nuclei staining in breast tissue (third-line metastatic setting).

The phase III ARTEST trial (ClinicalTrials.gov identifier NCT04869943) is currently enrolling patients to evaluate the efficacy of enobosarm monotherapy for patients with androgen receptor–positive, estrogen receptor–positive, HER2-negative metastatic breast cancer. This multicenter, randomized, open-label study has an estimated enrollment of 210 participants. Patients in the treatment arm will receive 9 mg of enobosarm daily by mouth until disease progression or an unacceptable adverse event is observed. Patients in the control arm will receive an estrogen receptor–targeted therapy limited to exemestane monotherapy, exemestane plus everolimus, or a selective estrogen receptor modulator approved for the treatment of breast cancer. The primary study endpoint is median radiographic progression-free survival, and the secondary outcome measure is objective response rate.

MorningStar

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