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news.Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).
Biostar Pharma plans to expand clinical trials for utidelone. Credit: Alex_Traksel/Shutterstock.com.
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Utidelone’s unique properties allow it to cross the blood-brain barrier (BBB), a capability supported by both preclinical and clinical studies.
A Phase II study involving utidelone in combination with etoposide and bevacizumab for HER2 negative BCBM patients demonstrated a central nervous system overall response rate (ORR) of 73% and a clinical benefit rate (CBR) of 91%.
Another Phase II trial showed a median progression-free survival (PFS) of 7.7 months and a 12-month overall survival (OS) rate of 74.4%. These promising results underpinned the FDA’s decision to grant ODD to utidelone.
Looking ahead, Biostar Pharma plans to expand the clinical trials for utidelone to include other brain tumour treatments, targeting conditions such as lung cancer brain metastasis and glioma within the current year.
Last year, the company said it was ready to advance UTD1 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the FDA for the study.
Utidelone is being derived from the synthetic biology technology platform of Biostar Pharma and is a genetically engineered epothilone analog.
