13 August 2026: Celltrion’s CT-P73 receives US FDA FTD for recurrent/metastatic Cervical cancer
Celltrion announced that the U.S. FDA has granted Fast Track designation to CT-P73, a Tissue Factor-targeted ADC, for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy, making it the third Celltrion ADC in clinical development to receive the designation alongside CT-P70 and CT-P71
CT-P73 demonstrated antitumor efficacy comparable to or superior to Tisotumab vedotin, with an improved safety profile in preclinical studies, supporting its development as a potential next-generation treatment option for recurrent or metastatic cervical cancer
The designation addresses a significant unmet need in recurrent and metastatic cervical cancer, where patients who progress after platinum-based chemotherapy have limited treatment options and require more effective and tolerable therapies
CT-P73 is a novel Tissue Factor-targeted antibody-drug conjugate designed to target Tissue Factor, which is overexpressed in cervical cancer and various other solid tumors
Strategically, the Fast Track designation strengthens Celltrion’s emerging ADC pipeline and enables closer engagement with the FDA to accelerate CT-P73’s development and regulatory pathway, while giving the company greater flexibility to pursue in-house commercialization or potential licensing opportunities based on clinical and market potential