FDA Grants Fast Track Status to CT-P71 in Urothelial Carcinoma

The FDA has granted fast track designation and rolling review status to Celltrion’s antibody-drug conjugate (ADC), CT-P71. The agent is undergoing evaluation in patients with locally advanced or metastatic urothelial carcinoma who have received prior therapy, according to the manufacturer. The dual designation grants the manufacturer rapid consultation with the FDA throughout the clinical development cycle.¹

Mechanism of Action: Nectin-4

CT-P71 functions by targeting Nectin-4, a protein highly expressed on tumor cells. Once it reaches its target, the agent's mechanism of action induces damage during the cancer cells’ DNA replication.

This approach has shown promise in preclinical studies, where the company reported superior anticancer efficacy compared with the existing treatment, enfortumab vedotin (Padcev).

Notably, CT-P71 demonstrated potent efficacy even in models resistant to current therapies. Clinical validation is underway; the first patient was dosed in phase 1 trials last September. These studies, which include patients with solid tumors and urothelial carcinoma, are reportedly progressing as planned.

Celltrion’s Fast Track Pipeline

This designation follows CT-P70’s fast track designation last December for metastatic non-squamous non–small cell lung cancer (NSCLC).² This agent targets cMET, which is often overexpressed in patients with high-risk NSCLC.

Following these dual designations, the company is expected to apply for fast track status for 2 other candidates, CT-P72 and CT-P73.

The FDA’s fast track program is designed to accelerate the development of therapies for serious conditions where current treatments fall short. By bridging the gap between developers and regulators, the designation facilitates frequent consultations throughout the entire clinical cycle. These benefits include streamlined communication on trial design, a higher probability of priority review, and the advantage of rolling review—a process that allows the FDA to evaluate sections of a drug application as they are completed, rather than waiting for the entire package.

REFERENCES

1. Lee H. Celltrion’s ADC candidate CT-P71 wins FDA Fast Track in urothelial cancer. Korea Biomedical Review. https://tinyurl.com/5han3j5c

2. MedPath. Celltrion's CT-P70 ADC Receives FDA Fast Track Designation for Metastatic Lung Cancer. December 4, 2025. Accessed April 9, 2026. https://tinyurl.com/55updesb