Celltrion is accelerating its push into the global oncology market, achieving consecutive milestones in the development of antibody-drug conjugate (ADC) therapies.
The company announced on April 9 that its ADC candidate CT-P71 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
This marks the second Fast Track designation for Celltrion’s ADC pipeline in just four months, following CT-P70, which was granted the same status in December last year for non-squamous non-small cell lung cancer (NSCLC). The back-to-back designations underscore the company’s growing competitiveness in high-demand cancer indications, including lung and urothelial cancers.
The FDA’s Fast Track program is designed to expedite the development and review of therapies targeting serious conditions with unmet medical needs. Companies granted Fast Track status benefit from more frequent interactions with the FDA throughout the clinical process, as well as eligibility for priority review, accelerated approval, and rolling review—measures that can significantly shorten the time to market.
CT-P71 targets Nectin-4, a protein highly expressed in tumor cells, and has demonstrated improved anti-tumor efficacy in preclinical studies compared to existing treatments. The candidate works by inducing damage during DNA replication, which may enable effectiveness even in treatment-resistant environments. Preclinical studies in non-human primates have also shown favorable safety results.
Celltrion is currently conducting Phase 1 clinical trials for CT-P71 and aims to develop the candidate into a best-in-class therapy based on its clinical data.
Building on this momentum, the company plans to extend its Fast Track strategy to its broader pipeline. Applications for additional candidates, including CT-P72 and CT-P73, are expected within the year, with a focus on leveraging expedited regulatory pathways to accelerate commercialization timelines.
A Celltrion official said the consecutive Fast Track designations reflect the recognition of the company’s therapies as meaningful treatment options in global clinical settings, adding that the company will continue to strengthen its innovative drug development capabilities to improve patient access.
Celltrion is targeting a total of 20 novel drug candidates in its portfolio by next year, as it ramps up discovery and development efforts across its pipeline.
