FDA Grants Fast Track Designation to ARV-110 in Metastatic Castration-Resistant Prostate Cancer
Posted: Monday, June 10, 2019
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARV-110 for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed after treatment with two or more systemic therapies.
The orally bioavailable proteolysis-targeting chimera protein degrader is designed to selectively target and reduce the androgen receptor protein. ARV-110 is currently being studied in a phase I clinical trial (ClinicalTrials.gov identifier NCT03888612) designed to evaluate the safety, tolerability, and pharmacokinetics of ARV-110 in men with metastatic castration-resistant prostate cancer whose disease has progressed after treatment with the standard of care.
In preclinical models, ARV-110 has demonstrated activity in androgen receptor mutation or overexpression. They are both common mechanisms of resistance to currently available androgen receptor–targeted therapies.
