Biostar Pharma Receives FDA Orphan Drug Designation for Utidelone in Pancreatic Cancer
Friday, September 26, 2025
Biostar Pharma has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for Utidelone in the treatment of pancreatic cancer.
Pancreatic cancer remains one of the most aggressive and difficult-to-treat malignancies, with vague early symptoms, rapid progression, and poor survival outcomes. The five-year survival rate stands at about 10 per cent, the lowest among major cancers. Standard therapy mainly relies on gemcitabine-based combinations, though treatment response is often limited by drug resistance.
Utidelone is a genetically engineered microtubule inhibitor available in injection (UTD1) and capsule (UTD2) forms. Compared with taxanes, it shows broader anti-tumour activity, reduced haematologic toxicity, and effectiveness against multidrug-resistant cancers. It also has the ability to cross the blood–brain barrier and offers high oral bioavailability. UTD1 was launched in China in 2021 for metastatic breast cancer, supported by Phase III trial results that showed improved progression-free and overall survival in patients previously treated with anthracycline- or taxane-based regimens.
This is the third ODD awarded to Utidelone, following earlier designations for breast cancer brain metastases and gastric cancer.
Preclinical studies have indicated that Utidelone can inhibit pancreatic cancer cell growth and strengthen the effect of gemcitabine. Data from a multicentre Phase II study, presented at the 2024 CSCO Annual Meeting, assessed Utidelone with gemcitabine as first-line treatment for advanced, unresectable pancreatic cancer.
Among 20 patients enrolled, 11 were evaluated: three achieved partial response and five showed stable disease, giving an objective response rate of 27.3 per cent and a disease control rate of 72.7 per cent. Median overall survival was 9.6 months.
Source: biostar-pharm.com
