Biostar Pharma Reports the US FDA’s IND Clearance for P-II Trial of Utidelone to Treat Breast Cancer Brain Metastasis
Shots:
- The US FDA has cleared the IND application for conducting a P-II study of utidelone injection (UTD1) for HER2- breast cancer brain metastasis (BCBM)
- The P-II (BG01-2402) trial assesses the intracranial and systemic efficacy of Utidelone Injection + capecitabine to treat patients (n=120) with HER2- BCBM across the US. 1EP includes CNS-ORR & 2EPs are PFS, DOR & OS
- A P-II study, highlighted at ASCO 2024, showed utidelone with bevacizumab had a CNS-ORR of 42.6%, mPFS of 7.7mos. & 12mos. OS rate of 74.4% in HER2- BCBM patients (n=47). In the HR-/HER2- subgroup, CNS-ORR was 55% with mPFS of 8.4mos.
Ref: PR Newswire | Image: Biostar Pharma
Related News:- Biostar Pharma’s Utidelone Injectable Receives the USFDA’s Orphan Drug Designation for Treating Breast Cancer Brain Metastasis
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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.
