Corbus Pharmaceuticals announces broad alignment with FDA on registration path for CRB-701 in second-line HNSCC and cervical cancer

CAR-T Digest - August 2020

Weekly Digest - April 2026

07 April 2026: Corbus Pharmaceuticals announces broad alignment with FDA on registration path for CRB-701 in second-line HNSCC and cervical cancer

Corbus Pharmaceuticals has achieved broad alignment with the FDA on the registration pathway for CRB-701, marking an important step toward advancing its Nectin-4 targeting ADC into late-stage development for second-line HNSCC and cervical cancer
This alignment allows the company to move forward with registrational trial designs, evaluating CRB-701 against standard-of-care therapies in these patient populations
The planned studies are designed to support accelerated approval based on ORR, with overall survival (OS) as the confirmatory endpoint for full approval
CRB-701 is a next-generation Nectin-4 ADC (MMAE payload), with prior Phase 1/2 data showing encouraging efficacy and safety findings at the ESMO 2025, and updated results to be presented at ASCO 2026
With regulatory alignment secured, Corbus is preparing to initiate registrational trials in 2026, marking a transition towards late-stage development and potential approval