Weekly Digest - August 2026

Weekly Digest - August 2026

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

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