Celltrion ADC drug candidates receive FDA Fast Track designation

Celltrion has announced that all three of its antibody-drug conjugate (ADC) cancer drug candidates currently in Phase 1 clinical trials—CT-P70, CT-P71, and CT-P73—have received Fast Track designation from the U.S. Food and Drug Administration (FDA).

The most recent designation, CT-P73, targets recurrent and metastatic cervical cancer in patients who have previously undergone platinum-based chemotherapy. CT-P73 targets tissue factor, a protein often overexpressed in various solid tumors. Non-clinical studies indicated that CT-P73 showed similar or superior anti-tumor effects and improved safety compared to existing treatments.

Celltrion is conducting Phase 1 trials for these candidates, which target c-MET, Nectin-4, and tissue factor, respectively. The company plans to complete Part 1 of Phase 1 trials for two candidates by the end of this year, with top-line results expected to be released sequentially starting in the first half of next year. CT-P70 is expected to enter Part 2 for dose optimization by March next year.

With these designations, Celltrion aims to utilize FDA benefits such as rolling reviews and increased opportunities for priority review and accelerated approval. The company intends to pursue a flexible commercialization strategy, choosing between direct commercialization and technology transfers to maximize long-term growth and early revenue.