Posted by Michael Wonder on 19 Jul 2023
FDA grants fast track designation for Ambrx’s ARX517 for the treatment of metastatic castration resistant prostate cancer
19 July 2023 - Ambrx Biopharma today announced that the US FDA has granted fast track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517, for the treatment of patients with metastatic castration resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.
ARX517 is currently being studied in APEX-01, a Phase 1/2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with metastatic castration resistant prostate cancer whose tumours have progressed on at least two prior FDA approved treatments for prostate cancer.
