FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and immunomodulatory agent.
Daratumumab is an investigational human monoclonal antibody with broad spectrum cytotoxic activity. It targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed.
The drug is currently in Phase I/II trials for multiple myeloma and has potential applicability against other malignancies on which CD38 is expressed.
According to FDA, breakthrough therapy designation is intended to expedite the development and review time for a potential new medicine “to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” ■