SN Bioscience’s SNB-101 Gains the US FDA’s Fast Track Designation for Small Cell Lung Cancer

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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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