Novel Agent Receives FDA Fast Track Designation in Urothelial Carcinoma

The FDA has granted fast track designation to CT-P71 for patients with locally advanced or metastatic urothelial carcinoma, according to a press release from Celltrion.¹

CT-P70 Mechanism of Action and Preclinical Results

CT-P71 is an antibody drug conjugate that target Nectin-4, which is observed in tumor cells. The press release highlighted that preclinical studies showed superior anticancer efficacy compared with enfortumab vedotin-ejfv (Padcev). Of note, the differentiator induces damage during DNA replication. Strong efficacy in resistance models has been noted, as well has safety compared with existing therapies, these results were presented in November 2025, at the World Antibody Drug Conjugate Conference.²

"We will do our best to accelerate a quantum leap into a new drug development company and swiftly provide innovative treatment options to patients worldwide,” a Celltrion official noted in the press release.

CT-P70 in NSCLC

CT-P70 is also being investigated for patients with EGFR non–small cell lung cancer (NSCLC).³ Results from the trial were also presented at the World Antibody Drug Conjugate Conference. Results showed a reduced cell viability and inhibition in a resistance model for third generation tyrosine kinase inhibitors. Efficacy was maintained not only in NSCLC, but also colorectal and gastric cancers.

Both CT-P71 and CT-P70 have received approval for phase 1 trial applications by the Ministry of Food and Drug Safety and the FDA.

In December 2025, the FDA granted fast track designation to CT-P70 for patients with metastatic non-squamous NSCLC who exhibit cMET. The press release noted that fast track designation was given after examining the target population and their limited treatment options with existing therapies.

Additional Treatment Options Under Development

Within 2026, Celltrion plans to submit fast track designation applications for CT-P72, which is a multi-specific antibody, and CT-P73. Looking at 2027, an investigational new drug application is being planned for CT-P74, and CT-P77, which is a FcRn inhibitor.⁴

An additional agent from Celltrion, CT-G32, is a quadruple agonist, and will activate 4 biological targets involving metabolism. This agent will help throughout cancer treatment with variable response and the risk of muscle loss. An investigational new drug application submission is planned for the second half of 2027.

References

1. Celltrion secures back-to-back FDA fast-track nods for ADC cancer pipeline. News release. Celltrion. April 9, 2026. Accessed April 10, 2026. https://tinyurl.com/364tnsk8
2. Celltrion unveils preclinical results for two ADC drug candidates at World ADC 2025. News release. Business Korea. November 7, 2025. https://tinyurl.com/4yvz7yzb
3. Celltrion's CT-P70 ADC receives FDA fast track designation for metastatic lung cancer. News release. MedPath. December 3, 2025. https://tinyurl.com/39fhprmw
4. [JPM 2026] Celltrion pitches 41-biosimilar roadmap and four phase 1 readouts at JPM. News release. Korea Biomedical Review. January 14, 2026. Accessed April 10, 2026. https://tinyurl.com/vtmbbhy3