
Jul 17 2025
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U.S. FDA has granted NuCana Fast Track Designation for Acelarin® for the Treatment of Biliary Tract Cancer.
Acelarin (NUC-1031), which is currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer, has been granted Fast Track designation by the U.S. FDA. Fast Track is intended to speed up the development and review of drugs that treat serious illnesses or meet an unmet medical need. The interventional, parallel assignment, single masking trial is expected to enroll 828 people, with a study completion date of December 2023.
Source: NuCana plc
Biliary tract cancer is a rare and heterogeneous malignant neoplasm with epithelial cell origin and histologic and biochemical characteristics. Any part of the bile duct epithelium, from the terminal ductules (Canals of Hering) to the ampulla of Vater and the peribiliary glands, can develop a malignant tumor. The cause of the abnormal proliferation in the bile ducts’ epithelial cells leading to tumors is unknown, and most cases occur sporadically. The majority of biliary tract cancers are adenocarcinomas with varying degrees of differentiation (mostly well-differentiated adenocarcinomas), though adenosquamous, squamous, mucinous, and anaplastic carcinomas are also seen.
- Approximately ~3,500 hospitalizations of Biliary tract cancer occur with an average incidence of between 0.45 to 2 cases per 100,000 population per year.
However, the current Biliary tract cancer treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (M7824, RC48-ADC, MRG003, Nivolumab, Bintrafusp alfa, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, U.K.) Japan and China.
In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Biliary tract cancer treatment. The key companies in the advanced development stage are EMD Serono, Jiangsu HengRui Medicine Co., Ltd., RemeGen Co., Ltd., Shanghai Miracogen Inc., etc.
Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Biliary tract cancer to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.
Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.
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