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Adcentrx Therapeutics Granted Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer

On May 6, 2025, the FDA granted Fast Track designation to Adcentrx Therapeutics' ADRX-0706 for advanced cervical cancer treatment.
This designation followed early clinical signals and addresses a significant unmet need for patients with progressing advanced cervical cancer.
ADRX-0706 is a Nectin-4-targeting antibody-drug conjugate currently in Phase 1b of a combined Phase 1a/b trial evaluating advanced solid tumors.
The FDA Fast Track program enables more frequent communication and rolling review, allowing earlier evaluation of NDA or BLA sections to accelerate therapy availability.
The designation may facilitate expedited development and regulatory benefits, supporting Adcentrx's advancement of ADRX-0706 as a promising treatment for advanced cervical cancer.

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Adcentrx Therapeutics Granted Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer

Fast Track designation underscores the potential for ADRX-0706 to address the high unmet need in advanced cervical cancer

25 days ago·Missoula, United States

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San Diego Business Journal

Adcentrx Receives Fast Track Designation for ‘Paradigm Shift’ Cancer Therapy - San Diego Business Journal

SAN DIEGO – Antibody-drug conjugate biotech company Adcentrx Therapeutics received Fast Track designation from the U.S. Food and Drug Administration for its lead program for patients with advanced cervical cancer. Adcentrx is currently studying the candidate, ADRX-0706, in the Phase 1b portion of a Phase 1a/b clinical trial, with preliminary signals that it is both […]

12 days ago

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