Fennec’s Pedmark Receives the US FDA’s Approval for the Treatment of Solid Tumors
Shots:
- The approval was based on the P-III (SIOPEL 6) & (COG ACCL0431) clinical trials evaluating the safety & efficacy data of Pedmark + cisplatin-based regimen vs cisplatin-based regimens alone in pediatric patients aged (>1mos.) with risk of cisplatin associated ototoxicity
- The result from the (SIOPEL 6) study demonstrated a consistent & significant reduction in hearing loss by 21.4% vs 73.3% whereas the (COG ACCL0431) study showed a reduction of 32.7% vs 63%. The study also showed a ≥85% increase in the 5yr. survival rate for patients
- Pedmark is formulated using sodium thiosulfate in single-dose vials for IV use in pediatric patients. Earlier, Pedmark has also received an ODD & a Priority Review designation from the US FDA in 2004
Ref: Fennec | Image: Fennec
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
