PR NEWSWIRE .
SEOUL, South Korea , May 9, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young -hwan) announced on May 7 that the FDA has Granted FAST TRACK Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a New Drug For Polymer Nanoparticle Anticancer under Clinical Trial .
SNB-101 was designated as an ORPHAN DRUG for SMALL CELL LUNG CÁNCER and Pancreatic Cancer in July of last Year and February of This Year, Respectively . By Receiving FAST-TRACK designation this time, it is Evaluated That it Has laid the Groundwork That Can Be Commercialized Immediately After Completion of PHASE II CLINICAL TRIALS .
Despite a long period of REsearch and Development, SCLC still remains a field with high medical Unmet Needs . Currently, the FIRST-LINE STANDARD Treatment is a Combination Therapy of CISPLATIN And ETOPÓSIDE, a classic cytotoxic Anticancer Drug, and ' CLINICAL TRIALS ' are included as SECOND-LINE Treatments in the NCCN GUIDELINES .
FAST TRACK is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need . The FAST TRACK Designation facilitates the interactions with the FDA and allows a Rolling REVIEW For the Submission Package so it can be Reviewed in each section, rather than waiting until every section of the NDA is Completed . Additionally, it May Be Possible To Apply For ACCELERATED APPROVAL After The Completion of PHASE II CLINICAL TRIALS and PRIORITY REVIEW Immediately After The Completion of PHASE III CLINICAL TRIALS When Qualified . ...