On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of patients with recurrent and metastatic cervical cancer who have previously received platinum based chemotherapy.
Fast-track designation is designed to accelerate the development and review of drugs intended to treat serious diseases and address unmet medical needs. A company that receives fast track designation for a drug may have more frequent meetings with FDA regarding the development plan and collection of data needed to support drug approval, may submit sections of its BLA/NDA for “rolling review” and the drug may be eligible for accelerated approval and priority review if relevant criteria are met.
Celltrion has two other ADCs, CT-P70 and CT-P71, which have also secured FDA fast-track designation. CT-P70 is being developed for the treatment of non-small cell lung cancer (NSCLC), while CT-P71 is undergoing evaluation in patients with locally advanced or metastatic urothelial carcinoma. All three ADCs are in phase 1 clinical trials.