SN Bioscience’s SNB-101 Gains the US FDA’s Fast Track Designation for Small Cell Lung Cancer
Shots:
- The US FDA has granted fast track designation to the company’s SNB-101 for small cell lung cancer (SCLC) on May 7. It was designated with the US FDA’s ODD for SCLC in Jul 2023 & pancreatic cancer in Feb 2024
- The P-I study of SNB-101 has been concluded & the IND for P-II is approved in Korea with global P-II study planned post IND approval across the US & EU in H2’24. The company also anticipates indication expansion to other solid tumors incl. colon cancer, gastric cancer & biliary tract cancer that will be confirmed via P-II study
- SNB-101, nanoparticle anticancer drug containing SN-38, showed favorable efficacy & reduction in digestive system AEs vs existing anticancer drugs in preclinical & P-I evaluations
Ref: SN Bioscience | Image: SN Bioscience
Related News:- SN BioScience’s SNB-101 Gains Orphan Drug Designation from the US FDA for the Treatment of Pancreatic Cancer
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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.