FDA grants Fast Track Designation to Corbus Pharmaceuticals Nectin-4 targeting ADC CRB-701 in head and neck squamous cell carcinoma

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Weekly Digest - September 2025

16 September 2025: FDA grants Fast Track Designation to Corbus Pharmaceuticals Nectin-4 targeting ADC CRB-701 in head and neck squamous cell carcinoma

Corbus Pharmaceuticals announced that the FDA granted Fast Track designation to CRB-701 for recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy and anti-PD(L)-1 therapy
This is the second Fast Track designation for CRB-701, following one in December 2024 for relapsed or refractory metastatic cervical cancer
CRB-701 (SYS6002) is a next-generation Nectin-4–targeting ADC with a site-specific cleavable linker, a precise drug-to-antibody ratio of 2, and MMAE as the payload
An ongoing Phase 1/2 trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in advanced solid tumors with high Nectin-4 expression; dose escalation data were presented at ASCO-GU 2025
Corbus will present the first dose-optimization data from this Phase 1/2 study at ESMO 2025 on October 19, 2025, with the trial primarily enrolling head and neck and cervical cancer patients