Celltrion said on the 9th that its antibody-drug conjugate (ADC) oncology drug candidate CT-P71 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
The FDA's Fast Track is a program for serious diseases for which existing treatments are not sufficiently effective, allowing drug developers and the FDA to hold expedited consultations across the entire clinical development cycle.
Once designated, corporations can benefit from: ▲ securing an ongoing communication channel with the FDA ▲ early consultations on clinical trial design and development strategies ▲ an increased likelihood of Priority Review and Accelerated Approval. In particular, they are granted eligibility for Rolling Review, which allows documents to be submitted and reviewed as they are ready, improving overall development efficiency.
CT-P71 is an ADC candidate that targets Nectin-4, observed in tumor cells. An ADC is a treatment technology that attaches a drug to an antibody to deliver it precisely to cancer cells. It consists of an antibody that homes to cancer cells, a payload that kills the cancer cells, and a linker for consolidation.
According to the company, in preclinical studies conducted earlier, it showed superior anticancer efficacy compared with the existing therapy Padcev (ingredient name enfortumab vedotin). Its differentiator is a mechanism of action that induces damage during the DNA replication process of cancer cells. It also demonstrated strong efficacy in resistance models to existing therapies, and, the company said, nonclinical evaluations in primates confirmed a markedly superior safety profile compared with existing therapies.
Celltrion began first dosing in a phase 1 clinical trial of CT-P71 in September last year for patients with solid tumors with limited treatment options, including urothelial carcinoma. The company said, "The trial is currently proceeding smoothly."
Another ADC drug candidate under development, CT-P70, also received FDA Fast Track designation in December last year. The target indication is metastatic non-squamous Non-small cell lung cancer (NSCLC).
A company official said, "Receiving Fast Track for CT-P71 in quick succession after CT-P70 recognizes the value of Celltrion's drug candidates as key therapies to address unmet needs in global clinical settings."
The company said it will make Fast Track designation a core strategy throughout future drug development, and will actively use accelerated approval and priority review to move up the timeline for global market launch. It plans to complete Fast Track applications within the year for follow-up candidates CT-P72 and CT-P73.
A Celltrion official said, "We will do our best to accelerate a quantum leap into a new drug development company and swiftly provide innovative treatment options to patients worldwide."