Corbus Pharmaceuticals Holdings, Inc. 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). This designation applies to patients previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy, addressing a significant unmet medical need in this patient population.
This marks the second Fast Track designation for CRB-701, a next-generation antibody drug conjugate (ADC) targeting Nectin-4. The first Fast Track designation was granted in December 2024 for relapsed or refractory metastatic cervical cancer. The dual designations underscore the FDA's recognition of CRB-701's potential across multiple challenging oncology indications.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This could potentially accelerate the clinical development and regulatory approval process for CRB-701 in HNSCC. Corbus will present the first data from its Phase 1/2 dose optimization study at ESMO 2025 on October 19, 2025, which included primarily HNSCC and cervical patients.
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