Health Canada to review Janssen’s NDS for daratumumab for Multiple Myeloma
November 18, 2015Health Canada has accepted for review Janssen’s new drug submission (NDS) for daratumumab for treatment of Multiple Myeloma.
Janssen announced on Wednesday that Health Canada would 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.
In addition, the European Medicines Agency has granted the medication’s application an Accelerated Assessment.
Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by excess growth and survival of malignant plasma cells. Patients who lapse after treatment often have a poor prognosis and few treatment options.
Janssen added that the submission for daratumumab is primarily supported by data from the Phase 2 SIRIUS study announced in May 2015, at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO).
