Celltrion ADC Candidates Win FDA Fast Track
All three antibody-drug conjugate (ADC)-based anticancer new drug candidates being developed by Celltrion have been named targets for the Fast Track designation by the U.S. Food and Drug Administration (FDA). As all items in the ADC pipeline that have entered the clinical stage have received the Fas
Celltrion has secured the U.S. Food and Drug Administration's (FDA) Fast Track designation for all three of its antibody-drug conjugate (ADC)-based anticancer new drug candidates. This designation is aimed at speeding up the development and commercialization of treatments for serious conditions with unmet medical needs. The ADC pipeline that has entered the clinical stage has all received this designation, which is expected to boost development speed and business strategy for new drug commercialization.
CT-P73, announced by Celltrion on August 13, has joined CT-P70 and CT-P71 in receiving the designation. This means all three ADC candidates currently in phase 1 clinical trials will receive intensive FDA support. Fast Track is a program designed to expedite the development of treatments for serious conditions with high unmet medical needs, offering close consultation with the FDA, the option for rolling review, and priority review and accelerated approval consideration in the future.
CT-P73 specifically targets patients with recurrent and metastatic cervical cancer, utilizing tissue factor as its target. In non-clinical studies, it demonstrated superior antitumor effects and improved safety compared to the existing treatment tisotumab vedotin. Celltrion is pursuing CT-P73 as a next-generation option to address unmet needs in cervical cancer patients.
The company plans to determine the optimal commercialization path for each candidate, whether through direct global commercialization or licensing out to strategic partners, adjusting investments based on each substance's competitiveness rather than applying a uniform strategy.
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