Celltrion's (068270.KS) antibody-drug conjugate (ADC) drug candidate CT-P71 has received Fast Track designation from the U.S. Food and Drug Administration (FDA). This marks the second such designation in just four months following CT-P70, accelerating the company's ADC-based anticancer drug development.
Celltrion announced Wednesday that CT-P71 received FDA Fast Track designation for patients with locally advanced or metastatic urothelial cancer who have received prior treatment. The designation follows the Fast Track status granted in December last year for CT-P70 targeting non-squamous non-small cell lung cancer (NSCLC).
Fast Track is an FDA program designed to expedite the development and review of treatments for serious conditions where existing therapies have shown insufficient efficacy. Developers receive benefits including ongoing consultation with the FDA, early discussion of clinical strategies, and expanded opportunities for priority review and accelerated approval. The program also allows rolling review, where data can be submitted sequentially, potentially shortening the overall development timeline.
CT-P71 is an ADC anticancer agent targeting Nectin-4, a protein expressed on tumor cells. Preclinical studies have demonstrated both improved anticancer efficacy and safety compared to existing treatments, with the drug also showing efficacy in resistance models. A Phase 1 clinical trial is currently underway in patients with solid tumors.
Building on this achievement, Celltrion plans to apply for Fast Track designation for its subsequent ADC candidates CT-P72 and CT-P73 within this year. "The ADC therapeutics market is a rapidly growing sector, and the market size targeted by CT-P71 is projected to reach approximately 7.7 trillion won ($5.5 billion) by 2032," a Celltrion official said. "We will apply the Fast Track strategy across our entire new drug pipeline to accelerate development and commercialization timelines."