Biostar Pharma’s Utidelone Injectable Receives the USFDA’s Orphan Drug Designation for Treating Breast Cancer Brain Metastasis
Shots:
- Biostar Pharma’s utidelone injectable (UTD1) has received the US FDA’s ODD to treat breast cancer brain metastasis (BCBM)
- The ODD was supported by the two P-II studies, one of them (n=17) assessing utidelone injectable + etoposide & bevacizumab resulted in 73% CNS ORR & 91% CNS CBR while the other one (n=46) evaluated utidelone injectable + bevacizumab & showed mPFS of 7.7mos. & 12mos. OS rate of 74.4% in HER2 -ve BCBM patients
- The company further anticipates the expansion of utidelone’s clinical evaluations for treating lung cancer brain metastasis & glioma based on its potential to cross BBB due to insusceptibility to P-glycoprotein-mediated efflux & physicochemical features
Ref: PR Newswire | Image: Biostar Pharma
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
