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Association details:
Biomarker:No biomarker
Cancer:Prostate Cancer
Drug:JNJ-8177 (Tubulin inhibitor, PSMA-targeted antibody-drug conjugate)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA Grants Fast Track Designation for Ambrx’s ARX517 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Published date:
07/19/2023
Excerpt:
Ambrx Biopharma...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate (ADC) investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor.