US EditionAdcentrx Therapeutics Granted Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer
- The FDA granted Fast Track designation on May 6, 2025, to Adcentrx Therapeutics' ADRX-0706 for advanced cervical cancer treatment.
- This designation addresses the critical need for effective therapies in individuals with squamous cell cervical cancer that has progressed or spread following initial treatment.
- ADRX-0706 is a proprietary Nectin-4 antibody-drug conjugate undergoing a Phase 1a/b clinical trial , with early data showing a favorable safety and pharmacokinetic profile.
- The FDA's Fast Track designation facilitates more frequent interactions during drug development and can provide regulatory advantages that speed up the evaluation process for ADRX-0706, including early submission and expedited assessment of application segments.
- This milestone promotes closer regulatory engagement and may expedite the approval process for ADRX-0706, which has demonstrated encouraging early clinical activity in a range of tumor indications, including 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
·Missoula, United States
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