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 announced on August 13 that its three clinical-stage antibody-drug conjugate (ADC) candidates have received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation includes CT-P73, CT-P70, and CT-P71, all currently in Phase 1 clinical development. CT-P73 targets Tissue Factor in cervical cancer, while CT-P70 and CT-P71 target c-MET and Nectin-4, respectively.
Fast Track designation allows for more frequent communication between developers and the FDA, as well as potential eligibility for Rolling Review and Accelerated Approval. Celltrion plans to evaluate clinical data and determine the best commercialization strategy for each candidate, whether that means direct development and sales or licensing agreements with global pharmaceutical companies.
The company believes this approach will maximize long-term value and opportunities for earlier monetization.
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