Glenmark's Ichnos receives FDA fast track for myeloma drug

Glenmark Pharmaceuticals announced today that its subsidiary, Ichnos Glenmark Innovation (IGI), has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ISB 2001. This designation targets the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously undergone at least three lines of therapy. ISB 2001 is an investigational trispecific antibody that targets BCMA and CD38 on myeloma cells and CD3 on T cells, currently in a Phase 1 dose-expansion study. The FDA's Fast Track program aims to accelerate the development and review of drugs that treat serious conditions and address unmet medical needs. Initial results from the Phase 1 study demonstrated a high overall response rate, with more complete results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. IGI previously received Orphan Drug Designation by the FDA for ISB 2001 in July 2023.