9 September 2015 - Janssen-Cilag International NV announced today it has submitted a new marketing authorisation application to the European Medicines Agency (EMA) for daratumumab, an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by excess growth and survival of malignant plasma cells. Patients who are refractory to both proteasome inhibitors (PIs) or immunomodulatory agents (IMiDs) have a poor prognosis, with an estimated median overall survival of nine months.

Daratumumab works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells. In doing so, daratumumab triggers the patient's own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.

The regulatory submission for daratumumab is now pending validation by the EMA and is based on data from the Phase 2 MMY2002 (SIRIUS) monotherapy study, which was presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), data from the Phase 1/2 GEN501 monotherapy study, which was recently published in The New England Journal of Medicine,9 and data from three supportive studies.

For more details, go to: http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=930810