Celltrion's antibody-drug conjugate (ADC) drug candidate CT-P71 has received Fast Track designation from the U.S. Food and Drug Administration, marking the company's second ADC-based cancer drug development milestone in just four months following CT-P70.
Celltrion (068270.KS) announced Wednesday that CT-P71 received FDA Fast Track designation for previously treated patients with locally advanced or metastatic urothelial cancer. The designation comes approximately four months after CT-P70 received the same status in December last year for metastatic non-squamous non-small cell lung cancer (NSCLC).
Fast Track is a program designed to expedite development and review of treatments for serious conditions where existing therapies have proven insufficient. Developers receive benefits including ongoing consultation with the FDA, early discussions on clinical trial design and development strategy, and expanded eligibility for priority review and accelerated approval. The program also enables "rolling review," allowing companies to submit documents sequentially for review, thereby shortening overall development timelines.
CT-P71 is an ADC drug candidate being developed to treat urothelial cancer. It targets Nectin-4, which is expressed on tumor cells, and features a mechanism that induces damage during DNA replication in cancer cells. According to Celltrion, preclinical studies confirmed superior anticancer efficacy and safety compared to existing treatments, with the drug also demonstrating effectiveness in resistance models. CT-P71 is currently in Phase 1 clinical trials for patients with solid tumors including urothelial cancer.
The ADC therapeutics market, which includes CT-P71, is growing rapidly. Celltrion projects the global market for its target indication to reach approximately 7.7 trillion won ($5.7 billion) by 2032.
Building on this Fast Track designation, Celltrion plans to accelerate development of subsequent ADC candidates. The company intends to apply for Fast Track designation for CT-P72 and CT-P73 within this year.
"Receiving Fast Track designation for CT-P71 shortly after CT-P70 validates the value of our drug candidates as treatments capable of addressing unmet medical needs," a Celltrion official said. "We plan to actively leverage the Fast Track program to advance global market launch and commercialization timelines."
