Celltrion Secures FDA Fast Track Designation for All Three Clinical-Stage ADC Candidates
Celltrion said on Aug. 13 that its antibody-drug conjugate (ADC) candidate CT-P73 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), bringing all three of the company’s clinical-stage ADC candidates under the expedited development program.The designation covers CT-
Celltrion has secured FDA Fast Track designation for all three of its clinical-stage antibody-drug conjugate (ADC) candidates, including CT-P73, CT-P70, and CT-P71. The FDA's Fast Track program aims to expedite the development and review of therapies for serious conditions with significant unmet medical needs. The three ADC candidates target c-MET, Nectin-4, and Tissue Factor, respectively, and are currently in Phase 1 clinical development.
By receiving Fast Track status for its entire clinical-stage ADC portfolio, Celltrion gains regulatory advantages and increased flexibility in determining the commercialization strategy for each candidate. For the most advanced candidate, CT-P73, which targets Tissue Factor overexpressed in cervical cancer and other solid tumors, preclinical studies have shown that it demonstrates antitumor activity comparable or superior to existing Tissue Factor-targeting therapy, while also presenting an improved safety profile.
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