HuMax CD38 (daratumumab) submitted to FDA in rolling submission for multiple myeloma- Janssen Biotech

Janssen Research & Development has initiated the rolling submission of its Biologic License Application (BLA) for HuMax CD38 (daratumumab) to the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

The regulatory submission for daratumumab will be primarily supported by data from the Phase II MMY2002 (SIRIUS) monotherapy study announced in May 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology, along with additional data from four other studies, including the Phase I/II GEN501 monotherapy study.