FDA Grants Fast Track Designation to SNB-101 in SCLC


SNB-101, a nanoparticle drug for small cell lung cancer, received a fast track designation from the FDA for expedited development and review.

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  • A fast track designation has been granted SNB-101 (SN-38) by the FDA for small cell lung cancer (SCLC).
  • SNB-101 is the first anticancer drug to be developed from SN-38 as nanoparticles.
  • Early data suggests improved tolerability and lung-specific efficacy with the agent.

The FDA has granted a fast track designation to SNB-101 for the treatment of patients with SCLC.1

SNB-101 is a new polymer nanoparticle anticancer drug currently undergoing evaluation in a clinical trial. In July 2023 and February 2024, the FDA granted an orphan drug designation to SNB-101 in small cell lung cancer and pancreatic cancer, respectively.2

With this fast-track designation, SNB-101 can be commercialized immediately following the completion of phase 2 clinical trials.1

Small cell lung cancer: © Констянтин Батыльчук- stock.adobe.com

Small cell lung cancer: © Констянтин Батыльчук- stock.adobe.com

About SNB-101

SNB-101 represents a breakthrough in cancer therapy as it is the first nanoparticle formulation of the potent antineoplastic agent SN-38. The agent utilizes SN Bioscience's proprietary dual nano-micelle technology and is made of extremely insoluble SN-3, which is an active metabolite of irinotecan, incorporated into polymer nanoparticles.

Early research, including preclinical studies and phase 1 clinical trials, have shown promise with SNB-101 demonstrating a significantly improved tolerability profile compared with conventional anticancer drugs. In these studies, SNB-101 reduced gastrointestinal adverse effects, including nausea, vomiting, and diarrhea, and has exhibited encouraging efficacy in patients with lung cancer due to targeted delivery to the lungs.

A phase 1 trial of the agent has already been successfully completed in Korea, and an investigational new drug (IND) approval for phase 2 is secured. Additionally, clinical trials are expected to begin across the globe later this year upon IND approval for phase 2 in the US and Europe.

Beyond its initial focus on small cell lung and pancreatic cancers, SNB-101 holds promise for a broader range of solid tumors, and phase 2 trials are planning to evaluate its efficacy in patients with colon cancer, gastric cancer, and biliary tract cancer.

1. SN Bioscience receives FDA fast track designation for small cell lung cancer. News release. SN Bioscience Co. Ltd. May 10, 2024. Accessed May 13, 2024. https://tinyurl.com/ymybhet7
2. SN BioScience received US FDA orphan drug designation for its nano anti-cancer drug ‘SNB-101’ on pancreatic cancer. News release. SN Bioscience Co. Ltd. February 29, 2024. Accessed May 13, 2024. https://tinyurl.com/yxr2km76
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