Celltrion announced on the 13th that its antibody-drug conjugate (ADC)-based anticancer drug candidate 'CT-P73' has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
With this designation, all three of Celltrion's ADC drug candidates currently in Phase 1 clinical trials (CT-P70, CT-P71, CT-P73) have been assigned Fast Track status. Moving forward, the company plans to comprehensively evaluate clinical data and market potential to strategically select candidates for in-house development and commercialization, as well as those for early revenue generation through technology transfers. This will broaden the strategic options for commercializing each pipeline.
The FDA Fast Track is a program designed to expedite the development and review of therapies for serious conditions where existing treatments are insufficient or where there is a high unmet medical need. It allows for close collaboration with the FDA throughout the development process, including support in designing clinical trials and establishing approval strategies. Eligible candidates can utilize a 'rolling review' process, submitting data sequentially as it becomes available, and may also qualify for priority review and accelerated approval considerations.
CT-P73's Fast Track designation targets the treatment of recurrent or metastatic cervical cancer patients with a history of platinum-based chemotherapy (PBC).
CT-P73, which Celltrion is developing in-house, is an ADC candidate targeting tissue factors overexpressed in various solid tumors, including cervical cancer. In non-clinical studies, it demonstrated comparable or superior antitumor efficacy and improved safety over tisotumab vedotin, an existing treatment. Based on these results, Celltrion is advancing CT-P73 as a next-generation treatment option to address the unmet medical needs of patients with recurrent or metastatic cervical cancer.
Currently, Celltrion is conducting Phase 1 trials for CT-P70 (targeting c-MET), CT-P71 (targeting nectin-4), and CT-P73 (targeting tissue factors). Two of the three ADC candidates are expected to complete Phase 1 Part 1 trials by the end of this year, with topline results to be announced sequentially starting in the first half of next year. The company also plans to rapidly proceed with Phase 1 Part 2 for dose optimization. Notably, CT-P70, the fastest-moving candidate, is targeted to enter Phase 1 Part 2 in March next year. Additionally, Celltrion intends to apply for FDA Fast Track designation for CT-P72, a multi-specific antibody candidate, by the end of the year.
A Celltrion representative stated, “By carefully evaluating clinical data and market potential, we will strategically choose between in-house development/commercialization and technology transfers for each candidate. This approach will enhance both the long-term growth potential of our new drugs and the possibility of early revenue generation.”
