Janssen's new drug submission for review by Health Canada

Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for daratumumab as a treatment for patients with multiple myeloma. Health Canada will review the submission with advance consideration under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) monotherapy study.
Daratumumab is a new class of therapy, a human anti-CD38 monoclonal antibody.  It received Breakthrough Therapy Designation and the Biologics License Application (BLA) was granted priority review and accelerated approval by the U.S. Food and Drug Administration (FDA) on November 16, 2015. The submission for daratumumab is primarily supported by data from the Phase 2 SIRIUS study. The study enrolled patients with multiple myeloma who had received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or were double refractory to a PI and an IMiD.³  The data presented showed daratumumab demonstrated a 29 per cent overall response rate and a tolerable safety profile in these heavily pre-treated patients.⁴ The submission also is supported with data from other studies, including the multi-centre, two-part open-label Phase 1/2 GEN501 monotherapy study. This study enrolled patients with multiple myeloma who had a relapse after, or had disease that was refractory to, two or more different prior therapies, including IMiDs, PIs, chemotherapy, and autologous stem-cell transplantation. The study showed daratumumab demonstrated a tolerable safety profile and a 36 per cent overall response rate in patients treated with a 16 mg/kg dose.