FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ CRB-701

Corbus Pharmaceuticals Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. This is the second Fast Track designation granted by the FDA for CRB-701, following one for relapsed or refractory metastatic cervical cancer in December 2024. CRB-701 is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, designed to facilitate the development and expedite the review of drugs intended to treat serious conditions that demonstrate the potential to fill an unmet medical need. The Company will present dose optimization data from the Phase 1/2 study at ESMO 2025.