Biostar Pharma announced that its core pipeline product Utidelone has once again been granted Orphan Drug Designation (ODD) by the FDA, for the treatment of pancreatic cancer. This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.
Pancreatic cancer is a highly malignant tumor known as the "king of cancers" due to its insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis. The five-year survival rate is only approximately 10%, far lower than that of other common cancers, making it the lowest among all malignant tumors. Currently, there is no clearly effective treatment for pancreatic cancer. Combination regimens based on gemcitabine remain the main clinical treatment, but due to the high tendency of pancreatic cancer cells to develop resistance to gemcitabine, treatment outcomes are often unsatisfactory.
The potential of Utidelone in treating pancreatic cancer has been well validated in both non-clinical and clinical studies. Preclinical data show that Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and exhibits strong anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone markedly reduces the IC50 value of gemcitabine without compromising its anti-tumor effect, and the combination demonstrates stronger anti-tumor activity compared with the traditional paclitaxel plus gemcitabine regimen. At the 2024 CSCO Annual Meeting, Biostar presented preliminary results from a multicenter, single-arm Phase II clinical study evaluating Utidelone combined with gemcitabine as first-line treatment for unresectable advanced pancreatic cancer. As of the report date, 20 advanced pancreatic cancer patients which were unresectable and ineligible for local treatment had been enrolled, with 11 completing their first efficacy evaluation. Among them, 3 patients achieved partial response (PR), and 5 achieved stable disease (SD); the objective response rate (ORR) was 27.27%, while the disease control rate (DCR) reached 72.72%. The median overall survival (mOS) was 9.57 months.
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