
Janssen submits EMA application for myeloma drug
pharmafile | September 14, 2015 | News story | Sales and Marketing | Janssen, daratumumab, multiple myeloma
Janssen has submitted a new marketing authorisation application for European approval of daratumumab for the treatment of patients with relapsed and refractory multiple myeloma.
Daratumumab is an investigational, human anti-CD38 monoclonal antibody for multiple myeloma, an incurable blood cancer that starts in the bone marrow and is characterised by excess growth and survival of malignant plasma cells.
It 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 mechanisms of action.
Janssen’s submission is based on data from a Phase II study. Daratumumab demonstrated a tolerable safety profile and achieved an ORR of 36%. Median progression-free survival was 5.6 months with 65% of patients remaining in remission at 12 months. The overall survival rate at 12 months was 77%.
Dr Rozlyn Bekker, medical director at Janssen UK, says: “For more than a decade Janssen has focused on addressing unmet needs in multiple myeloma which, despite important advances, still remains an incurable cancer.
“At Janssen, we remain committed to addressing the needs of blood cancer patients across the world. Whilst we cannot predict the EMA response, we hope that this is the first step towards making this treatment available to people with multiple myeloma in the UK.”
Yasmita Kumar
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