FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma
Corbus Pharmaceuticals Holdings, Inc. (CRBP)
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Source: GlobeNewswire
Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025Second Fast Track designation granted by FDA for CRB-701 NORWOOD, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today 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. A Fast Track designation for relapsed or refractory metastatic cervical cancer was granted by the FDA in December 2024. CRB-701 (SYS6002) is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio of 2 using MMAE as the payload. The FDA’s Fast Track designation is designed to facilitate the dev
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