Glenmark’s GBR 1342 Receives the US FDA’s Orphan Drug Designation for Multiple Myeloma

Glenmark’s GBR 1342 Receives the US FDA’s Orphan Drug Designation for Multiple Myeloma

Shots:

  • The US FDA has granted Orphan drug designation to GBR 1342 for the treatment of multiple myeloma who have received prior therapies. The P-I study will assess the safety & tolerability of increasing doses of GBR 1342 and will evaluate biomarkers, immunogenicity, and additional measures of disease activity
  • The ODD is granted to novel drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases affecting people less than 200,000 in the US
  • GBR 1342 is a bispecific investigational Ab based on Glenmark’s BEAT technology and is designed to bind to both CD3 and CD38, activating T cells and redirecting them toward CD38+ tumor cells found in multiple myeloma

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