Janssen submits MAA to European Medicines Agency for daratumumab in multiple myeloma

Daratumumab is an investigational, human anti-CD38 monoclonal antibody, which is designed to treat patients with relapsed and refractory multiple myeloma.

Multiple myeloma is an incurable blood cancer that begins in the bone marrow and is characterized by an excess proliferation of plasma cells.

Daratumumab binds with high affinity to the CD38, a signalling molecule identified on the surface of multiple myeloma cells.

It triggers own immune system of the patient to attack the cancer cells, resulting in rapid tumour cell death via multiple immune-mediated mechanisms.

Five Phase III clinical studies with daratumumab in relapsed and frontline settings are underway.

In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Earlier this month, the US Food and Drug Administration accepted priority review to Janssen Research & Development biologics license application (BLA) for daratumumab.

Janssen company group chairman responsible for Europe, Middle East and Africa Jane Griffiths said: "Through our continued commitment to research into new therapies and innovative mechanisms, we are encouraged to see the depth of therapeutic response with daratumumab.

"This is particularly promising for relapsed and refractory patients who have a poor prognosis and may already have exhausted all existing treatment options. We look forward to working with the EMA to make daratumumab available for people with multiple myeloma."

There were around 39,000 new multiple myeloma cases in Europe in 2012. It commonly affects people over the age of 65 and is more common in men than in women.

Janssen said throughout Europe, five-year survival rates are 23% to 47% of people diagnosed.

Image: Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab. Photo: courtesy of Lars Møller/Jeroen Bouman/Marieke de Lorijn.