by ecancer reporter Vanessa Lane

This month has seen a fast track designation for daratumumab by the US FDA. This designation covers patients with multiple myeloma (MM) who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or are double refractory to a PI and an IMiD.

Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity and is in Phase I/II clinical development for MM. Daratumumab has multiple mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), apoptosis and modulation of CD38 enzymatic activity. In pre-clinical studies, daratumumab has been shown to effectively kill MM cells and to enhance the potency of other MM treatments.