[Song Young Doo, Edaily Reporter] Celltrion announced on the 4th that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its antibody-drug conjugate (ADC) oncology candidate CT-P70.

The FDA‘s Fast Track program is intended for serious conditions where existing treatments do not provide sufficient benefit. It allows sponsors to interact more frequently and efficiently with the FDA throughout development. Companies with a Fast Track–designated product gain access to continuous communication channels with the agency, early discussions on clinical trial design and development strategy, and an increased likelihood of Priority Review and Accelerated Approval, as well as the option of Rolling Review. Together, these measures can significantly shorten the overall time to potential approval.

CT-P70 is being developed as a new treatment option for patients with metastatic non-squamous non-small cell lung cancer(NSCLC) whose tumors express cMET and who have previously received systemic therapy. The program received Investigational New Drug(IND) clearance from the FDA in March this year, and a Phase 1 trial is now under way with patient dosing in progress.

According to Celltrion, the FDA’s decision reflects both the high-risk nature of this patient population, which has limited benefit from existing therapies, and the potential suggested by CT-P70‘s early development data.

Celltrion plans to use the Fast Track Designation not only to accelerate development of CT-P70 but also to build a broader, streamlined “rapid development framework” for its pipeline. The company intends to file additional Fast Track applications sequentially for its follow-on ADC and multispecific antibody candidates, including CT-P71, CT-P72 and CT-P73.

By the end of this year, Celltrion aims to have a total of four new drug candidates, including CT-P70, in clinical development. The company plans to expand its pipeline to about 20 assets by 2027, with more than 10 of them in clinical stages.

To support this strategy, Celltrion is combining its in-house R&D capabilities with collaborations across a wide range of partners to secure platform technologies in areas such as ADCs and multispecific antibodies. Its goal is to enhance technological competitiveness by ensuring high scalability across antibody–chemical conjugation approaches and formulation types. Beyond the platforms it has already established, the company is working to strengthen technologies that can deliver higher therapeutic indices by improving both efficacy and safety, through internal development and expanded partnerships with multiple domestic and global firms.

“The Fast Track Designation for CT-P70 is formal recognition from the FDA that Celltrion’s new drug has the potential to address unmet medical needs as a new therapeutic option,” a Celltrion official said. “Building on this designation, we plan to continue applying for Fast Track status for our ADC and multispecific antibody candidates in development, and ultimately accelerate development so we can bring new treatment options to patients as quickly as possible.”