Celltrion announced Thursday that CT-P70, its novel antibody-drug conjugate candidate for lung cancer, has received fast track designation from the US Food and Drug Administration.
ADCs are next-generation therapies that connect a powerful cancer-killing drug to an antibody. This design allows the treatment to directly attack cancer cells while minimizing damage to healthy tissue.
The fast track designation, granted to drugs addressing serious conditions with unmet medical needs, facilitates more frequent communication with the FDA and allows for priority review of a new drug application, potentially speeding up the approval process.
CT-P70 is designed for patients with metastatic lung cancer who have not responded to existing systemic therapies. It is currently in Phase 1 clinical trials, following investigational new drug approval from the FDA in March.
Celltrion said the FDA’s decision underscores both the urgent need for additional treatment options for high-risk patients and the promising potential shown in the company’s early-stage development data.
Leveraging the milestone, the company plans to establish a “rapid development system” for CT-P70 as well as future modalities, including additional ADCs and multispecific antibodies.
“This designation officially confirms CT-P70’s potential to address unmet medical needs,” a Celltrion official said. “We will accelerate development to provide a new treatment option to patients as quickly as possible.”
The company aims to have four novel drug candidates in clinical trials by the end of this year and expand its pipeline to 20 novel drugs by 2027.
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