FDA grants priority review to HuMax CD38 (daratumumab) in multiple myeloma- Janssen Biotech

The FDA has granted Priority Review to the Biologics License Application (BLA) for HuMax CD38 (daratumumab), from Janssen Biotech. The BLA is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD.

The BLA submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation for this indication from the FDA in May 2013.

The average survival rate for the disease is only three to four years with conventional treatment such as Velcade (Takeda/J&J) and Revlimid (Celgene). In addition, the late-stage study of elotuzumab from BMS, combined with Revlimid and dexamethasone, produced an improvement in progression free survival of 4.5 months–19.4 months in the drug arm compared to 14.9 months for the standard therapy approach.