Celltrion’s ADC anticancer drug ‘CT-P70’ receives Fast Track Designation from the US FDA

CAR-T Digest - August 2020

04 December 2025: Celltrion’s ADC anticancer drug ‘CT-P70’ receives Fast Track Designation from the US FDA

Celltrion’s ADC candidate CT-P70 has received FDA Fast Track Designation for metastatic non-squamous NSCLC patients expressing cMET who have already undergone systemic therapy
The designation was granted in recognition of the high-risk nature of this patient group and the promising early development data supporting CT-P70, which received IND clearance in March 2025, and is now progressing through Phase 1 clinical evaluation
With Fast Track status, Celltrion gains several regulatory advantages, including continuous FDA engagement, early input on trial design, rolling review, and the potential for priority review or accelerated approval, all of which could meaningfully speed the path to market
Building on this momentum, the company also plans to pursue Fast Track designation for additional ADC and multi-antibody programs (CT-P71, CT-P72, and CT-P73) as part of its effort to advance four new drugs into clinical trials by the end of the year
These efforts tie into Celltrion’s broader strategy to establish a 20-asset new-drug portfolio by 2027, supported by expanded platform technologies and strategic collaborations aimed at accelerating innovation in ADC and multi-antibody development