Celltrion announced on Thursday that its antibody-drug conjugate (ADC) candidate, CT-P71, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for treating patients with previously treated locally advanced or metastatic urothelial carcinoma.
This designation allows for an expedited review process.
This milestone comes just four months after CT-P70 received Fast Track designation for metastatic non-squamous non-small cell lung cancer (NSCLC) last December.
Celltrion has successfully demonstrated the value of its ADC pipeline in high-risk cancers with significant unmet medical needs, such as lung cancer and urothelial carcinoma, setting the stage for its emergence as a global player in new drug development.
The FDA’s Fast Track program facilitates swift interactions between developers and the FDA for serious conditions lacking adequate treatment options, streamlining the clinical development process.
Fast Track designation offers developers benefits including ongoing communication with the FDA, early input on clinical trial design and development strategies, and increased potential for Priority Review and Accelerated Approval.
The designation also grants eligibility for a Rolling Review, allowing developers to submit sections of their application as they’re completed, maximizing overall development efficiency and potentially shortening the timeline to new drug approval.
CT-P71, the newly designated candidate, is an ADC being developed to treat urothelial carcinoma. It targets Nectin-4, a protein found in tumor cells, and has shown superior anti-cancer effects in preclinical studies compared to the existing treatment Padcev (enfortumab vedotin).
Notably, CT-P71 employs a novel mechanism of action that damages cancer cells during DNA replication, demonstrating strong efficacy even against tumors resistant to existing therapies. Preclinical evaluations in primates also revealed significantly better safety profiles compared to current treatments.
A Celltrion spokesperson stated that securing Fast Track designation for both CT-P70 and CT-P71 in such rapid succession underscores the potential of Celltrion’s drug candidates to address critical unmet needs in global healthcare. It’s committed to accelerating the growth as a innovative drug developer and bringing cutting-edge treatment options to patients worldwide as quickly as possible.
Meanwhile, Celltrion aims to ramp up its new drug discovery efforts as part of its strategy to build a portfolio of 20 novel drug candidates by next year.