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Corbus Says FDA Grants Fast-Track Designation to Head and Neck Cancer Drug
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Corbus Says FDA Grants Fast-Track Designation to Head and Neck Cancer Drug
Sep 16, 2025 5:53 AM

08:28 AM EDT, 09/16/2025 (MT Newswires) -- Corbus Pharmaceuticals ( CRBP ) said Tuesday that its head and neck squamous cell carcinoma drug CRB-701 was granted Fast Track designation by the US Food and Drug Administration.

The company said that a phase 1/2 trial is currently evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression.

Fast-track designation is intended 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 said.

Corbus said it will present dose optimization data from the study next month at the European Society for Medical Oncology.

Corbus shares were 4.5% higher in premarket trading.

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