Celltrion Wins U.S. Fast Track for All Three ADC Candidates

What happened

Celltrion said all three of its antibody-drug conjugate (ADC) candidates in clinical development — CT-P70, CT-P71 and CT-P73 — have received Fast Track designation from the U.S. FDA. The designation for CT-P73 covers recurrent or metastatic cervical cancer in patients previously treated with platinum-based chemotherapy. Two of the three candidates will complete Part 1 of their Phase 1 trials within this year and begin releasing topline results in the first half of next year. CT-P70 is aiming to enter Part 2 in March next year. Celltrion also plans to apply to the FDA within this year for Fast Track designation for CT-P72, a multispecific antibody-based candidate.

Why it matters

Fast Track designation can speed development and review for treatments addressing serious conditions with high unmet medical need. It allows more frequent FDA consultation and potential rolling review, though it does not guarantee approval. With all three ADC candidates carrying the designation, Celltrion aims to improve development efficiency and differentiate strategies for each pipeline. The company is also expanding beyond ADCs into multispecific antibodies to build a long-term growth engine following its biosimilar business.